Study of Kidney Tumors in Younger Patients

Renal Tumors Classification, Biology, and Banking Study

Sponsors

Lead Sponsor: Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Source Children's Oncology Group
Brief Summary

This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Detailed Description

PRIMARY OBJECTIVES: I. Classify patients with renal tumors by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies. (Loss of heterozygosity [LOH] testing discontinued as of April 2014) II. Maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists. SECONDARY OBJECTIVES: I. Monitor outcome for those patients who are not eligible for a subsequent therapeutic study. II. Describe whether the pulmonary tumor burden correlates with outcome in stage IV patients. (Completed as of Amendment 7) III. Describe the sensitivity and specificity of abdominal computed tomography (CT) by comparison with surgical and pathologic findings for identification of local tumor spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver. (Completed as of Amendment 7) IV. Compare the sensitivity and specificity of pre-operative abdominal CT scan and magnetic resonance imaging (MRI) for the identification and differentiation of nephrogenic rests and Wilms' tumor in children with multiple renal lesions. (Completed as of Amendment 7) V. Correlate the method of conception (natural vs assisted reproductive technology) with the development of Wilms' tumor. (Completed as of Amendment 7) VI. To evaluate the frequency of integrase interactor 1 (INI1) mutations in renal and extrarenal malignant rhabdoid tumor of the kidney and to determine the incidence of germline and inherited versus somatic mutations to facilitate clinical correlations on the companion study AREN0321. (INI1 testing discontinued as of April 2014) (Completed as of Amendment 7) OUTLINE: Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and MRIs are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies. (LOH and INI1 testing discontinued as of April 2014) Patients are followed up periodically for 5 years.

Overall Status Recruiting
Start Date 2006-02-27
Primary Completion Date 2100-01-01
Study Type Observational
Primary Outcome
Measure Time Frame
Event-free survival Up to 5 years from study enrollment
Overall survival Up to 5 years from study enrollment
Secondary Outcome
Measure Time Frame
Loss of heterozygosity (LOH testing discontinued as of April 2014) Baseline
Enrollment 5000
Condition
Intervention

Intervention Type: Other

Intervention Name: Cytology Specimen Collection Procedure

Description: Correlative studies

Arm Group Label: Ancillary-correlative (renal tumor classification, biology)

Other Name: Cytologic Sampling

Intervention Type: Other

Intervention Name: Laboratory Biomarker Analysis

Description: Correlative studies

Arm Group Label: Ancillary-correlative (renal tumor classification, biology)

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - Patients with the first occurrence of any tumor of the kidney identified on CT scan or MRI are eligible for this study; histologic diagnosis is not required prior to enrollment but is required for all patients once on study - Eligible tumors include (but are not limited to): - Nephroblastic tumors - Nephroblastoma (Wilms' tumor) (favorable histology, anaplasia [diffuse, focal]) - Nephrogenic rests and nephroblastomatosis - Cystic nephroma and cystic partially differentiated nephroblastoma - Metanephric tumors (metanephric adenoma, metanephric adenofibroma, metanephric stromal tumor) - Mesoblastic nephroma (cellular, classic, mixed) - Clear cell sarcoma - Rhabdoid tumor (any malignant rhabdoid tumor occurring outside the central nervous system [CNS]) - Renal epithelioid tumors of childhood (papillary renal cell carcinoma, medullary renal cell carcinoma, renal tumors associated with Xp11.2 translocations, oncocytic renal neoplasms after neuroblastoma) - Angiolipoma - Ossifying renal tumor of infancy - Patients with the first occurrence of the following tumors are also eligible: - Extrarenal nephroblastoma or extrarenal neprogenic rests - Malignant rhabdoid tumor occurring anywhere outside the central nervous system - Required specimens, reports, forms, and copies of imaging studies must be available or will become available for submission and the institution must intend on submitting them as described in the protocol procedures - For ALL patients, (with exception of bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy***), the following submissions are required: - A complete set of recut hematoxylin and eosin (H & E) slides (including from sampled lymph nodes, if patient had upfront nephrectomy) - * Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed favorable histology Wilms tumor [FHWT] patients discovered to have diffuse anaplastic Wilms tumor [DAWT] at delayed nephrectomy and plan to enroll at delayed nephrectomy) - Representative formalin-fixed paraffin-embedded tissue block or if a block is unavailable, 10 unstained slides from a representative block of tumor, if available. - Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed FHWT patients discovered to have DAWT at delayed nephrectomy and plan to enroll at delayed nephrectomy) - Institutional pathology report, Specimen Transmittal Form, and Pre-Treatment Pathology Checklist - Copies of images and institutional reports of CT and/or MRI abdomen and pelvis, and Pre Treatment Imaging Checklist - Copies of images and institutional report of chest CT for all malignant tumors - Institutional surgical report(s) and Pre-Treatment Surgical Checklist - CRFs: Staging Checklist and Metastatic Disease Form (if metastatic disease is noted on imaging) - Patients with bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy via imaging only - these patients will not have central review or have a risk assignment issued, but may contribute to specimen banking for future research. However, if biopsy is done, tissue must be submitted as for other renal tumors, and initial risk assignment will require pathology and surgical rapid central reviews. The Specimen Transmittal Form and Pre Treatment Pathology Checklist are also needed. - Please note: if the above required items are not received within 120 days of study enrollment, the patient will be considered off study - All patients and/or their parents or legal guardians must sign a written informed consent - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Gender:

All

Minimum Age:

N/A

Maximum Age:

29 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Elizabeth A Mullen Principal Investigator Children's Oncology Group
Location
Facility: Status: Contact: Investigator:
Children's Hospital of Alabama | Birmingham, Alabama, 35233, United States Recruiting Site Public Contact 205-638-9285 [email protected] Matthew A. Kutny Principal Investigator
University of Alabama at Birmingham Cancer Center | Birmingham, Alabama, 35233, United States Active, not recruiting
USA Health Strada Patient Care Center | Mobile, Alabama, 36604, United States Recruiting Site Public Contact 800-388-8721 Hamayun Imran Principal Investigator
Providence Alaska Medical Center | Anchorage, Alaska, 99508, United States Recruiting Site Public Contact 907-212-6871 [email protected] Brenda J. Wittman Principal Investigator
Phoenix Childrens Hospital | Phoenix, Arizona, 85016, United States Recruiting Site Public Contact 602-546-0920 Jessica Boklan Principal Investigator
Banner University Medical Center - Tucson | Tucson, Arizona, 85719, United States Recruiting Site Public Contact [email protected] Holly E. Pariury Principal Investigator
Arkansas Children's Hospital | Little Rock, Arkansas, 72202-3591, United States Recruiting Site Public Contact 501-364-7373 David L. Becton Principal Investigator
University of Arkansas for Medical Sciences | Little Rock, Arkansas, 72205, United States Active, not recruiting
Kaiser Permanente Downey Medical Center | Downey, California, 90242, United States Recruiting Site Public Contact 626-564-3455 Robert M. Cooper Principal Investigator
City of Hope Comprehensive Cancer Center | Duarte, California, 91010, United States Recruiting Site Public Contact 800-826-4673 [email protected] Anna B. Pawlowska Principal Investigator
Loma Linda University Medical Center | Loma Linda, California, 92354, United States Recruiting Site Public Contact 909-558-4050 Albert Kheradpour Principal Investigator
Miller Children's and Women's Hospital Long Beach | Long Beach, California, 90806, United States Recruiting Site Public Contact 562-933-5600 Jacqueline N. Casillas Principal Investigator
Children's Hospital Los Angeles | Los Angeles, California, 90027, United States Recruiting Site Public Contact 323-361-4110 Leo Mascarenhas Principal Investigator
Cedars Sinai Medical Center | Los Angeles, California, 90048, United States Recruiting Site Public Contact 310-423-8965 Fataneh (Fae) Majlessipour Principal Investigator
Mattel Children's Hospital UCLA | Los Angeles, California, 90095, United States Recruiting Site Public Contact 310-825-6708 William A. May Principal Investigator
Valley Children's Hospital | Madera, California, 93636, United States Recruiting Site Public Contact 559-353-3000 [email protected] Karen S. Fernandez Principal Investigator
Children's Hospital and Research Center at Oakland | Oakland, California, 94609-1809, United States Recruiting Site Public Contact 510-428-3324 [email protected] Carla B. Golden Principal Investigator
Kaiser Permanente-Oakland | Oakland, California, 94611, United States Recruiting Site Public Contact 877-642-4691 [email protected] Laura A. Campbell Principal Investigator
Children's Hospital of Orange County | Orange, California, 92868, United States Recruiting Site Public Contact 714-509-8646 [email protected] Elyssa M. Rubin Principal Investigator
Lucile Packard Children's Hospital Stanford University | Palo Alto, California, 94304, United States Recruiting Site Public Contact 800-694-0012 [email protected] Jay Michael S. Balagtas Principal Investigator
Sutter Medical Center Sacramento | Sacramento, California, 95816, United States Recruiting Site Public Contact 415-209-2686 [email protected] Yung S. Yim Principal Investigator
University of California Davis Comprehensive Cancer Center | Sacramento, California, 95817, United States Recruiting Site Public Contact 916-734-3089 Marcio H. Malogolowkin Principal Investigator
Rady Children's Hospital - San Diego | San Diego, California, 92123, United States Recruiting Site Public Contact 858-966-5934 William D. Roberts Principal Investigator
Naval Medical Center -San Diego | San Diego, California, 92134, United States Recruiting Site Public Contact 619-532-8712 Yoko T. Udaka Principal Investigator
UCSF Medical Center-Parnassus | San Francisco, California, 94143, United States Active, not recruiting
UCSF Medical Center-Mission Bay | San Francisco, California, 94158, United States Recruiting Site Public Contact 877-827-3222 Arun A. Rangaswami Principal Investigator
Santa Barbara Cottage Hospital | Santa Barbara, California, 93102, United States Recruiting Site Public Contact 805-682-7300 David J. Slomiany Principal Investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance, California, 90502, United States Recruiting Site Public Contact 310-222-3624 [email protected] Eduard H. Panosyan Principal Investigator
Children's Hospital Colorado | Aurora, Colorado, 80045, United States Recruiting Site Public Contact 303-764-5056 [email protected] Timothy P. Garrington Principal Investigator
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver, Colorado, 80218, United States Recruiting Site Public Contact 303-839-6000 Jennifer J. Clark Principal Investigator
Connecticut Children's Medical Center | Hartford, Connecticut, 06106, United States Recruiting Site Public Contact 860-545-9981 Michael S. Isakoff Principal Investigator
Yale University | New Haven, Connecticut, 06520, United States Recruiting Site Public Contact 203-785-5702 [email protected] Nina S. Kadan-Lottick Principal Investigator
Alfred I duPont Hospital for Children | Wilmington, Delaware, 19803, United States Recruiting Site Public Contact 302-651-6884 [email protected] Ramamoorthy Nagasubramanian Principal Investigator
MedStar Georgetown University Hospital | Washington, District of Columbia, 20007, United States Recruiting Site Public Contact 202-444-2223 Jeffrey A. Toretsky Principal Investigator
Children's National Medical Center | Washington, District of Columbia, 20010, United States Recruiting Site Public Contact 202-884-2549 Jeffrey S. Dome Principal Investigator
Broward Health Medical Center | Fort Lauderdale, Florida, 33316, United States Recruiting Site Public Contact 954-355-5346 Hector M. Rodriguez-Cortes Principal Investigator
Lee Memorial Health System | Fort Myers, Florida, 33901, United States Active, not recruiting
Golisano Children's Hospital of Southwest Florida | Fort Myers, Florida, 33908, United States Recruiting Site Public Contact 239-343-5333 [email protected] Emad K. Salman Principal Investigator
University of Florida Health Science Center - Gainesville | Gainesville, Florida, 32610, United States Suspended
Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood, Florida, 33021, United States Recruiting Site Public Contact 954-265-1847 [email protected] Iftikhar Hanif Principal Investigator
Nemours Children's Clinic-Jacksonville | Jacksonville, Florida, 32207, United States Recruiting Site Public Contact 904-697-3529 Ramamoorthy Nagasubramanian Principal Investigator
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida, 33136, United States Recruiting Site Public Contact 305-243-2647 Julio C. Barredo Principal Investigator
Nicklaus Children's Hospital | Miami, Florida, 33155, United States Recruiting Site Public Contact 888-624-2778 Enrique A. Escalon Principal Investigator
Miami Cancer Institute | Miami, Florida, 33176, United States Recruiting Site Public Contact 786-596-2000 Doured Daghistani Principal Investigator
AdventHealth Orlando | Orlando, Florida, 32803, United States Recruiting Site Public Contact 407-303-2090 [email protected] Fouad M. Hajjar Principal Investigator
Arnold Palmer Hospital for Children | Orlando, Florida, 32806, United States Recruiting Site Public Contact 321-841-2008 [email protected] Amy A. Smith Principal Investigator
Nemours Children's Clinic - Orlando | Orlando, Florida, 32806, United States Active, not recruiting
UF Cancer Center at Orlando Health | Orlando, Florida, 32806, United States Active, not recruiting
Nemours Children's Hospital | Orlando, Florida, 32827, United States Recruiting Site Public Contact 407-650-7715 Ramamoorthy Nagasubramanian Principal Investigator
Nemours Children's Clinic - Pensacola | Pensacola, Florida, 32504, United States Active, not recruiting
Johns Hopkins All Children's Hospital | Saint Petersburg, Florida, 33701, United States Recruiting Site Public Contact 727-767-4784 [email protected] Jonathan L. Metts Principal Investigator
Tampa General Hospital | Tampa, Florida, 33606, United States Active, not recruiting
Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa, Florida, 33607, United States Suspended
Saint Mary's Hospital | West Palm Beach, Florida, 33407, United States Recruiting Site Public Contact 561-881-2815 Narayana Gowda Principal Investigator
Children's Healthcare of Atlanta - Egleston | Atlanta, Georgia, 30322, United States Recruiting Site Public Contact 404-785-2025 [email protected] Bradley A. George Principal Investigator
Augusta University Medical Center | Augusta, Georgia, 30912, United States Recruiting Site Public Contact 706-721-2388 [email protected] Colleen H. McDonough Principal Investigator
Medical Center of Central Georgia | Macon, Georgia, 31201, United States Recruiting Site Public Contact 478-633-2152 [email protected] Sushmita Nair Principal Investigator
Memorial Health University Medical Center | Savannah, Georgia, 31404, United States Recruiting Site Public Contact 912-350-7887 [email protected] Andrew L. Pendleton Principal Investigator
University of Hawaii Cancer Center | Honolulu, Hawaii, 96813, United States Active, not recruiting
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii, 96826, United States Recruiting Site Public Contact 808-983-6090 Wade T. Kyono Principal Investigator
Tripler Army Medical Center | Honolulu, Hawaii, 96859, United States Active, not recruiting
Saint Luke's Mountain States Tumor Institute | Boise, Idaho, 83712, United States Recruiting Site Public Contact 208-381-2774 [email protected] Eugenia Chang Principal Investigator
Lurie Children's Hospital-Chicago | Chicago, Illinois, 60611, United States Recruiting Site Public Contact 773-880-4562 Amy L. Walz Principal Investigator
University of Illinois | Chicago, Illinois, 60612, United States Recruiting Site Public Contact 312-355-3046 Mary L. Schmidt Principal Investigator
University of Chicago Comprehensive Cancer Center | Chicago, Illinois, 60637, United States Suspended
Loyola University Medical Center | Maywood, Illinois, 60153, United States Suspended
Advocate Children's Hospital-Oak Lawn | Oak Lawn, Illinois, 60453, United States Recruiting Site Public Contact 847-723-7570 Rebecca E. McFall Principal Investigator
Advocate Children's Hospital-Park Ridge | Park Ridge, Illinois, 60068, United States Recruiting Site Public Contact [email protected] Rebecca E. McFall Principal Investigator
Advocate Lutheran General Hospital | Park Ridge, Illinois, 60068, United States Active, not recruiting
Saint Jude Midwest Affiliate | Peoria, Illinois, 61637, United States Recruiting Site Public Contact 888-226-4343 Jaime M. Libes Principal Investigator
Southern Illinois University School of Medicine | Springfield, Illinois, 62702, United States Recruiting Site Public Contact 217-545-7929 Gregory P. Brandt Principal Investigator
Riley Hospital for Children | Indianapolis, Indiana, 46202, United States Suspended
Saint Vincent Hospital and Health Care Center | Indianapolis, Indiana, 46260, United States Suspended
Blank Children's Hospital | Des Moines, Iowa, 50309, United States Recruiting Site Public Contact 515-241-8912 [email protected] Samantha L. Mallory Principal Investigator
University of Iowa/Holden Comprehensive Cancer Center | Iowa City, Iowa, 52242, United States Recruiting Site Public Contact 800-237-1225 Mariko Sato Principal Investigator
University of Kansas Cancer Center | Kansas City, Kansas, 66160, United States Completed
University of Kentucky/Markey Cancer Center | Lexington, Kentucky, 40536, United States Suspended
Norton Children's Hospital | Louisville, Kentucky, 40202, United States Recruiting Site Public Contact 502-629-5500 [email protected] Ashok B. Raj Principal Investigator
Tulane University Health Sciences Center | New Orleans, Louisiana, 70112, United States Active, not recruiting
Children's Hospital New Orleans | New Orleans, Louisiana, 70118, United States Recruiting Site Public Contact [email protected] Lolie C. Yu Principal Investigator
Ochsner Medical Center Jefferson | New Orleans, Louisiana, 70121, United States Recruiting Site Public Contact 504-703-8712 [email protected] Craig Lotterman Principal Investigator
Eastern Maine Medical Center | Bangor, Maine, 04401, United States Recruiting Site Public Contact 207-973-4274 Nadine P. SantaCruz Principal Investigator
Maine Children's Cancer Program | Scarborough, Maine, 04074, United States Recruiting Site Public Contact 207-396-7581 [email protected] Eric C. Larsen Principal Investigator
University of Maryland/Greenebaum Cancer Center | Baltimore, Maryland, 21201, United States Recruiting Site Public Contact 800-888-8823 Teresa A. York Principal Investigator
Sinai Hospital of Baltimore | Baltimore, Maryland, 21215, United States Recruiting Site Public Contact 410-601-6120 [email protected] Jason M. Fixler Principal Investigator
Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore, Maryland, 21287, United States Recruiting Site Public Contact 410-955-8804 [email protected] Alan D. Friedman Principal Investigator
Walter Reed National Military Medical Center | Bethesda, Maryland, 20889-5600, United States Recruiting Site Public Contact 301-319-2100 Kenneth Lieuw Principal Investigator
Floating Hospital for Children at Tufts Medical Center | Boston, Massachusetts, 02111, United States Recruiting Site Public Contact 617-636-5535 Jason Law Principal Investigator
Massachusetts General Hospital Cancer Center | Boston, Massachusetts, 02114, United States Recruiting Site Public Contact 877-726-5130 Elizabeth A. Mullen Principal Investigator
Dana-Farber Cancer Institute | Boston, Massachusetts, 02215, United States Recruiting Site Public Contact 877-442-3324 Elizabeth A. Mullen Principal Investigator
Baystate Medical Center | Springfield, Massachusetts, 01199, United States Suspended
UMass Memorial Medical Center - University Campus | Worcester, Massachusetts, 01655, United States Recruiting Site Public Contact 508-856-3216 [email protected] Stefanie R. Lowas Principal Investigator
C S Mott Children's Hospital | Ann Arbor, Michigan, 48109, United States Recruiting Site Public Contact 800-865-1125 Rajen Mody Principal Investigator
Wayne State University/Karmanos Cancer Institute | Detroit, Michigan, 48201, United States Recruiting Site Public Contact 313-576-9790 [email protected] Alissa M. Martin Principal Investigator
Ascension Saint John Hospital | Detroit, Michigan, 48236, United States Recruiting Site Public Contact 734-712-3671 [email protected] Adonis N. Lorenzana Principal Investigator
Michigan State University Clinical Center | East Lansing, Michigan, 48824-7016, United States Recruiting Site Public Contact 517-975-9547 Aghiad Chamdin Principal Investigator
Hurley Medical Center | Flint, Michigan, 48503, United States Active, not recruiting
Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids, Michigan, 49503, United States Suspended
Bronson Methodist Hospital | Kalamazoo, Michigan, 49007, United States Recruiting Site Public Contact 616-391-1230 [email protected] Katharina E. Elliott Principal Investigator
Kalamazoo Center for Medical Studies | Kalamazoo, Michigan, 49008, United States Active, not recruiting
Beaumont Children's Hospital-Royal Oak | Royal Oak, Michigan, 48073, United States Recruiting Site Public Contact 248-551-7695 Laura K. Gowans Principal Investigator
William Beaumont Hospital-Royal Oak | Royal Oak, Michigan, 48073, United States Active, not recruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota, 55404, United States Suspended
University of Minnesota/Masonic Cancer Center | Minneapolis, Minnesota, 55455, United States Recruiting Site Public Contact 612-624-2620 Emily G. Greengard Principal Investigator
Mayo Clinic in Rochester | Rochester, Minnesota, 55905, United States Recruiting Site Public Contact 855-776-0015 Carola A. Arndt Principal Investigator
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States Suspended
Columbia Regional | Columbia, Missouri, 65201, United States Recruiting Site Public Contact [email protected] Barbara A. Gruner Principal Investigator
Children's Mercy Hospitals and Clinics | Kansas City, Missouri, 64108, United States Recruiting Site Public Contact 816-302-6808 [email protected] Keith J. August Principal Investigator
Cardinal Glennon Children's Medical Center | Saint Louis, Missouri, 63104, United States Recruiting Site Public Contact 314-268-4000 William S. Ferguson Principal Investigator
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Recruiting Site Public Contact 800-600-3606 [email protected] David B. Wilson Principal Investigator
Mercy Hospital Saint Louis | Saint Louis, Missouri, 63141, United States Recruiting Site Public Contact 314-251-7066 Robin D. Hanson Principal Investigator
Children's Hospital and Medical Center of Omaha | Omaha, Nebraska, 68114, United States Recruiting Site Public Contact 402-955-3949 Minnie Abromowitch Principal Investigator
University of Nebraska Medical Center | Omaha, Nebraska, 68198, United States Recruiting Site Public Contact 402-559-6941 [email protected] Minnie Abromowitch Principal Investigator
University Medical Center of Southern Nevada | Las Vegas, Nevada, 89102, United States Recruiting Site Public Contact 702-384-0013 [email protected] Alan K. Ikeda Principal Investigator
Sunrise Hospital and Medical Center | Las Vegas, Nevada, 89109, United States Recruiting Site Public Contact 702-384-0013 [email protected] Alan K. Ikeda Principal Investigator
Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas, Nevada, 89135, United States Recruiting Site Public Contact 702-384-0013 [email protected] Alan K. Ikeda Principal Investigator
Summerlin Hospital Medical Center | Las Vegas, Nevada, 89144, United States Suspended
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States Recruiting Site Public Contact 800-639-6918 [email protected] Julie Kim Principal Investigator
Hackensack University Medical Center | Hackensack, New Jersey, 07601, United States Recruiting Site Public Contact 201-996-2879 Burton E. Appel Principal Investigator
Saint Barnabas Medical Center | Livingston, New Jersey, 07039, United States Active, not recruiting
Morristown Medical Center | Morristown, New Jersey, 07960, United States Recruiting Site Public Contact 973-971-5900 John J. Gregory Principal Investigator
Saint Peter's University Hospital | New Brunswick, New Jersey, 08901, United States Recruiting Site Public Contact 732-745-8600 6163 [email protected] Nibal A. Zaghloul Principal Investigator
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick, New Jersey, 08903, United States Recruiting Site Public Contact 732-235-8675 Richard A. Drachtman Principal Investigator
Newark Beth Israel Medical Center | Newark, New Jersey, 07112, United States Suspended
Saint Joseph's Regional Medical Center | Paterson, New Jersey, 07503, United States Recruiting Site Public Contact 973-754-2207 [email protected] Alissa Kahn Principal Investigator
Overlook Hospital | Summit, New Jersey, 07902, United States Active, not recruiting
University of New Mexico Cancer Center | Albuquerque, New Mexico, 87102, United States Recruiting Site Public Contact 505-925-0366 [email protected] John F. Kuttesch Principal Investigator
Albany Medical Center | Albany, New York, 12208, United States Recruiting Site Public Contact 518-262-5513 Lauren R. Weintraub Principal Investigator
Montefiore Medical Center - Moses Campus | Bronx, New York, 10467, United States Recruiting Site Public Contact 718-379-6866 [email protected] Lisa Gennarini Principal Investigator
Brooklyn Hospital Center | Brooklyn, New York, 11201, United States Active, not recruiting
Roswell Park Cancer Institute | Buffalo, New York, 14263, United States Suspended
NYU Winthrop Hospital | Mineola, New York, 11501, United States Recruiting Site Public Contact 646-754-4624 [email protected] Mark E. Weinblatt Principal Investigator
The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park, New York, 11040, United States Suspended
Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York, New York, 10016, United States Suspended
Mount Sinai Hospital | New York, New York, 10029, United States Recruiting Site Public Contact 212-824-7309 [email protected] Pillai Pallavi Madhusoodhan Principal Investigator
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York, New York, 10032, United States Recruiting Site Public Contact 212-305-6361 [email protected] Alice Lee Principal Investigator
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States Suspended
NYP/Weill Cornell Medical Center | New York, New York, 10065, United States Suspended
University of Rochester | Rochester, New York, 14642, United States Suspended
Stony Brook University Medical Center | Stony Brook, New York, 11794, United States Recruiting Site Public Contact 800-862-2215 Laura E. Hogan Principal Investigator
State University of New York Upstate Medical University | Syracuse, New York, 13210, United States Recruiting Site Public Contact 315-464-5476 Philip M. Monteleone Principal Investigator
New York Medical College | Valhalla, New York, 10595, United States Recruiting Site Public Contact 914-594-3794 Jessica C. Hochberg Principal Investigator
Mission Hospital | Asheville, North Carolina, 28801, United States Recruiting Site Public Contact 828-418-1354 [email protected] Douglas J. Scothorn Principal Investigator
UNC Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina, 27599, United States Recruiting Site Public Contact 877-668-0683 [email protected] Stuart H. Gold Principal Investigator
Carolinas Medical Center/Levine Cancer Institute | Charlotte, North Carolina, 28203, United States Recruiting Site Public Contact 800-804-9376 Joel A. Kaplan Principal Investigator
Novant Health Presbyterian Medical Center | Charlotte, North Carolina, 28204, United States Recruiting Site Public Contact 704-384-5369 [email protected] Jessica A. Bell Principal Investigator
Duke University Medical Center | Durham, North Carolina, 27710, United States Recruiting Site Public Contact 888-275-3853 Lars M. Wagner Principal Investigator
East Carolina University | Greenville, North Carolina, 27834, United States Suspended
Wake Forest University Health Sciences | Winston-Salem, North Carolina, 27157, United States Recruiting Site Public Contact 336-713-6771 David E. Kram Principal Investigator
Sanford Broadway Medical Center | Fargo, North Dakota, 58122, United States Recruiting Site Public Contact 701-323-5760 [email protected] Samuel J. Milanovich Principal Investigator
Children's Hospital Medical Center of Akron | Akron, Ohio, 44308, United States Recruiting Site Public Contact 330-543-3193 Steven J. Kuerbitz Principal Investigator
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, 45229, United States Recruiting Site Public Contact 513-636-2799 [email protected] James I. Geller Principal Investigator
Rainbow Babies and Childrens Hospital | Cleveland, Ohio, 44106, United States Recruiting Site Public Contact 216-844-5437 Duncan S. Stearns Principal Investigator
Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States Recruiting Site Public Contact 866-223-8100 [email protected] Rabi Hanna Principal Investigator
Nationwide Children's Hospital | Columbus, Ohio, 43205, United States Recruiting Site Public Contact 614-072-2657 [email protected] Mark A. Ranalli Principal Investigator
Dayton Children's Hospital | Dayton, Ohio, 45404, United States Recruiting Site Public Contact 800-228-4055 Ayman A. El-Sheikh Principal Investigator
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo, Ohio, 43606, United States Recruiting Site Public Contact 419-824-1842 Jamie L. Dargart Principal Investigator
Mercy Children's Hospital | Toledo, Ohio, 43608, United States Suspended
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, 73104, United States Recruiting Site Public Contact 405-271-8777 [email protected] Rene Y. McNall-Knapp Principal Investigator
Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa, Oklahoma, 74136, United States Recruiting Site Public Contact 918-494-2200 Gregory B. Kirkpatrick Principal Investigator
Legacy Emanuel Children's Hospital | Portland, Oregon, 97227, United States Recruiting Site Public Contact 503-413-2560 Janice F. Olson Principal Investigator
Legacy Emanuel Hospital and Health Center | Portland, Oregon, 97227, United States Active, not recruiting
Oregon Health and Science University | Portland, Oregon, 97239, United States Recruiting Site Public Contact 503-494-1080 [email protected] Katrina Winsnes Principal Investigator
Lehigh Valley Hospital-Cedar Crest | Allentown, Pennsylvania, 18103, United States Suspended
Lehigh Valley Hospital - Muhlenberg | Bethlehem, Pennsylvania, 18017, United States Suspended
Geisinger Medical Center | Danville, Pennsylvania, 17822, United States Recruiting Site Public Contact 570-271-5251 [email protected] Jagadeesh Ramdas Principal Investigator
Penn State Children's Hospital | Hershey, Pennsylvania, 17033, United States Recruiting Site Public Contact 717-531-6012 Lisa M. McGregor Principal Investigator
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, 19104, United States Recruiting Site Public Contact 267-425-5544 [email protected] Frank M. Balis Principal Investigator
Saint Christopher's Hospital for Children | Philadelphia, Pennsylvania, 19134, United States Recruiting Site Public Contact 215-427-8991 Gregory E. Halligan Principal Investigator
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania, 15224, United States Recruiting Site Public Contact 412-692-8570 [email protected] Arthur K. Ritchey Principal Investigator
Rhode Island Hospital | Providence, Rhode Island, 02903, United States Recruiting Site Public Contact 401-444-1488 Jennifer J. Greene Welch Principal Investigator
Medical University of South Carolina | Charleston, South Carolina, 29425, United States Recruiting Site Public Contact 843-792-9321 [email protected] Jacqueline M. Kraveka Principal Investigator
Prisma Health Richland Hospital | Columbia, South Carolina, 29203, United States Recruiting Site Public Contact 803-434-3533 Stuart L. Cramer Principal Investigator
BI-LO Charities Children's Cancer Center | Greenville, South Carolina, 29605, United States Recruiting Site Public Contact 864-522-2066 [email protected] Nichole L. Bryant Principal Investigator
Greenville Cancer Treatment Center | Greenville, South Carolina, 29605, United States Active, not recruiting
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota, 57117-5134, United States Recruiting Site Public Contact 605-312-3320 [email protected] Kayelyn J. Wagner Principal Investigator
T C Thompson Children's Hospital | Chattanooga, Tennessee, 37403, United States Suspended
East Tennessee Childrens Hospital | Knoxville, Tennessee, 37916, United States Recruiting Site Public Contact 865-541-8266 Ray C. Pais Principal Investigator
Saint Jude Children's Research Hospital | Memphis, Tennessee, 38105, United States Recruiting Site Public Contact 888-226-4343 [email protected] Rachel C. Brennan Principal Investigator
The Children's Hospital at TriStar Centennial | Nashville, Tennessee, 37203, United States Recruiting Site Public Contact 615-342-1919 Haydar A. Frangoul Principal Investigator
Vanderbilt University/Ingram Cancer Center | Nashville, Tennessee, 37232, United States Recruiting Site Public Contact 800-811-8480 Daniel J. Benedetti Principal Investigator
Texas Tech University Health Sciences Center-Amarillo | Amarillo, Texas, 79106, United States Recruiting Site Public Contact 806-354-5411 Samer Zaid Kaylani Principal Investigator
Dell Children's Medical Center of Central Texas | Austin, Texas, 78723, United States Recruiting Site Public Contact 512-628-1902 [email protected] Shannon M. Cohn Principal Investigator
Driscoll Children's Hospital | Corpus Christi, Texas, 78411, United States Recruiting Site Public Contact 361-694-5311 [email protected] Nkechi I. Mba Principal Investigator
Medical City Dallas Hospital | Dallas, Texas, 75230, United States Recruiting Site Public Contact 972-566-5588 Stanton C. Goldman Principal Investigator
UT Southwestern/Simmons Cancer Center-Dallas | Dallas, Texas, 75390, United States Recruiting Site Public Contact 214-648-7097 [email protected] Jonathan E. Wickiser Principal Investigator
Brooke Army Medical Center | Fort Sam Houston, Texas, 78234, United States Suspended
Cook Children's Medical Center | Fort Worth, Texas, 76104, United States Recruiting Site Public Contact 682-885-2103 [email protected] Kelly L. Vallance Principal Investigator
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston, Texas, 77030, United States Recruiting Site Public Contact 713-798-1354 [email protected] Valeria Smith Principal Investigator
M D Anderson Cancer Center | Houston, Texas, 77030, United States Recruiting Site Public Contact 877-632-6789 [email protected] Najat C. Daw Principal Investigator
Covenant Children's Hospital | Lubbock, Texas, 79410, United States Recruiting Site Public Contact [email protected] Kishor M. Bhende Principal Investigator
UMC Cancer Center / UMC Health System | Lubbock, Texas, 79415, United States Recruiting Site Public Contact 806-775-8590 Mohamad M. Al-Rahawan Principal Investigator
Children's Hospital of San Antonio | San Antonio, Texas, 78207, United States Recruiting Site Public Contact [email protected] Timothy C. Griffin Principal Investigator
Methodist Children's Hospital of South Texas | San Antonio, Texas, 78229, United States Recruiting Site Public Contact 210-575-6240 [email protected] Vinod K. Gidvani-Diaz Principal Investigator
University of Texas Health Science Center at San Antonio | San Antonio, Texas, 78229, United States Recruiting Site Public Contact 210-450-3800 [email protected] Anne-Marie R. Langevin Principal Investigator
Scott and White Memorial Hospital | Temple, Texas, 76508, United States Suspended
Primary Children's Hospital | Salt Lake City, Utah, 84113, United States Suspended
University of Vermont and State Agricultural College | Burlington, Vermont, 05405, United States Recruiting Site Public Contact 802-656-8990 [email protected] Jessica L. Heath Principal Investigator
University of Virginia Cancer Center | Charlottesville, Virginia, 22908, United States Recruiting Site Public Contact 434-243-6303 [email protected] William C. Petersen Principal Investigator
Inova Fairfax Hospital | Falls Church, Virginia, 22042, United States Recruiting Site Public Contact 703-208-6650 [email protected] Marshall A. Schorin Principal Investigator
Children's Hospital of The King's Daughters | Norfolk, Virginia, 23507, United States Recruiting Site Public Contact 757-668-7243 [email protected] Eric J. Lowe Principal Investigator
Naval Medical Center - Portsmouth | Portsmouth, Virginia, 23708-2197, United States Active, not recruiting
Virginia Commonwealth University/Massey Cancer Center | Richmond, Virginia, 23298, United States Recruiting Site Public Contact 804-628-1914 [email protected] Madhu S. Gowda Principal Investigator
Carilion Children's | Roanoke, Virginia, 24014, United States Recruiting Site Public Contact 540-266-6238 [email protected] Erwood G. Edwards Principal Investigator
Seattle Children's Hospital | Seattle, Washington, 98105, United States Recruiting Site Public Contact 866-987-2000 Sarah E. Leary Principal Investigator
Providence Sacred Heart Medical Center and Children's Hospital | Spokane, Washington, 99204, United States Recruiting Site Public Contact 800-228-6618 [email protected] Judy L. Felgenhauer Principal Investigator
Mary Bridge Children's Hospital and Health Center | Tacoma, Washington, 98405, United States Recruiting Site Public Contact 253-403-1461 [email protected] Robert G. Irwin Principal Investigator
Madigan Army Medical Center | Tacoma, Washington, 98431, United States Recruiting Site Public Contact 253-968-0129 [email protected] Melissa A. Forouhar Principal Investigator
West Virginia University Charleston Division | Charleston, West Virginia, 25304, United States Recruiting Site Public Contact 304-388-9944 Mohamad H. Badawi Principal Investigator
Cabell-Huntington Hospital | Huntington, West Virginia, 25701, United States Completed
Saint Vincent Hospital Cancer Center Green Bay | Green Bay, Wisconsin, 54301, United States Recruiting Site Public Contact 920-433-8889 [email protected] Catherine A. Long Principal Investigator
University of Wisconsin Hospital and Clinics | Madison, Wisconsin, 53792, United States Recruiting Site Public Contact 800-622-8922 Kenneth B. De Santes Principal Investigator
Marshfield Medical Center-Marshfield | Marshfield, Wisconsin, 54449, United States Recruiting Site Public Contact 800-782-8581 [email protected] Michelle A. Manalang Principal Investigator
Children's Hospital of Wisconsin | Milwaukee, Wisconsin, 53226, United States Recruiting Site Public Contact 414-955-4727 [email protected] Meghen B. Browning Principal Investigator
John Hunter Children's Hospital | Hunter Regional Mail Centre, New South Wales, 2310, Australia Recruiting Site Public Contact (02) 4985 5180 Bhavna Padhye Principal Investigator
Sydney Children's Hospital | Randwick, New South Wales, 2031, Australia Recruiting Site Public Contact (02) 9382-1721 Bhavna Padhye Principal Investigator
The Children's Hospital at Westmead | Westmead, New South Wales, 2145, Australia Recruiting Site Public Contact 61-2-9845 1400 Bhavna Padhye Principal Investigator
Royal Brisbane and Women's Hospital | Herston, Queensland, 4029, Australia Active, not recruiting
Royal Children's Hospital-Brisbane | Herston, Queensland, 4029, Australia Active, not recruiting
Queensland Children's Hospital | South Brisbane, Queensland, 4101, Australia Recruiting Site Public Contact 61 7 3068 1111 Steven A. Foresto Principal Investigator
Women's and Children's Hospital-Adelaide | North Adelaide, South Australia, 5006, Australia Recruiting Site Public Contact (08) 8161 7327 [email protected] Maria L. Kirby Principal Investigator
Monash Medical Center-Clayton Campus | Clayton, Victoria, 3168, Australia Suspended
Royal Children's Hospital | Parkville, Victoria, 3052, Australia Suspended
Princess Margaret Hospital for Children | Perth, Western Australia, 6008, Australia Active, not recruiting
Perth Children's Hospital | Perth, Western Australia, 6009, Australia Suspended
Alberta Children's Hospital | Calgary, Alberta, T3B 6A8, Canada Recruiting Site Public Contact 403-220-6898 [email protected] Douglas R. Strother Principal Investigator
University of Alberta Hospital | Edmonton, Alberta, T6G 2B7, Canada Recruiting Site Public Contact 780-407-6615 [email protected] Sarah J. McKillop Principal Investigator
British Columbia Children's Hospital | Vancouver, British Columbia, V6H 3V4, Canada Recruiting Site Public Contact 604-875-2345 6477 David B. Dix Principal Investigator
CancerCare Manitoba | Winnipeg, Manitoba, R3E 0V9, Canada Suspended
Janeway Child Health Centre | Saint John's, Newfoundland and Labrador, A1B 3V6, Canada Recruiting Site Public Contact 866-722-1126 Lisa A. Goodyear Principal Investigator
IWK Health Centre | Halifax, Nova Scotia, B3K 6R8, Canada Recruiting Site Public Contact 902-470-8037 [email protected] Craig Erker Principal Investigator
McMaster Children's Hospital at Hamilton Health Sciences | Hamilton, Ontario, L8N 3Z5, Canada Suspended
Kingston Health Sciences Centre | Kingston, Ontario, K7L 2V7, Canada Recruiting Site Public Contact 613-549-6666 [email protected] Mariana P. Silva Principal Investigator
Children's Hospital | London, Ontario, N6A 5W9, Canada Suspended
Children's Hospital of Eastern Ontario | Ottawa, Ontario, K1H 8L1, Canada Recruiting Site Public Contact 613-738-3931 Donna L. Johnston Principal Investigator
Hospital for Sick Children | Toronto, Ontario, M5G 1X8, Canada Suspended
The Montreal Children's Hospital of the MUHC | Montreal, Quebec, H3H 1P3, Canada Suspended
Centre Hospitalier Universitaire Sainte-Justine | Montreal, Quebec, H3T 1C5, Canada Suspended
Allan Blair Cancer Centre | Regina, Saskatchewan, S4T 7T1, Canada Active, not recruiting
Saskatoon Cancer Centre | Saskatoon, Saskatchewan, S7N 4H4, Canada Suspended
Centre Hospitalier Universitaire de Quebec | Quebec, G1V 4G2, Canada Suspended
Schneider Children's Medical Center of Israel | Petah Tikua, 49202, Israel Suspended
Starship Children's Hospital | Grafton, Auckland, 1145, New Zealand Suspended
Christchurch Hospital | Christchurch, 8011, New Zealand Suspended
Wellington Children's Hospital | Wellington, 6002, New Zealand Completed
San Jorge Children's Hospital | San Juan, 00912, Puerto Rico Suspended
University Pediatric Hospital | San Juan, 00926, Puerto Rico Recruiting Site Public Contact 787-474-0333 Maria E. Echevarria Principal Investigator
Swiss Pediatric Oncology Group - Bern | Bern, 3010, Switzerland Suspended
Location Countries

Australia

Canada

Israel

New Zealand

Puerto Rico

Switzerland

United States

Verification Date

2020-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Ancillary-correlative (renal tumor classification, biology)

Description: Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and MRIs are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies. (LOH and INI1 testing discontinued as of April 2014)

Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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