- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01109394
Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies
Background:
- Laboratory investigators who are studying common childhood cancers are interested in developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of children who have cancer or adults who have common childhood cancers. To develop this repository, additional samples will be collected from children and adults who have been diagnosed with common childhood cancers such as leukemia and tumors of the central nervous system.
Objectives:
- To collect and store blood, serum, tissue, urine, or tumor samples of children who have cancer or adults who have common childhood cancers.
Eligibility:
- Individuals who have been diagnosed with a common childhood cancer (e.g., leukemia) regardless of patient age.
- Children, adolescents, and adults who have been diagnosed with a type of cancer more commonly found in adults.
Design:
- Extra blood, serum (the liquid part of blood), tissue, urine, or tumor samples will be collected from participants at a time when sampling is required for medical care or as part of a research study.
- No additional procedures will be performed for the sole purpose of obtaining additional tumor tissue, aside from what is required for clinical care.
Study Overview
Status
Detailed Description
Background:
-Laboratory-based investigations have contributed to an improved understanding of the biology of cancer and to the development of new therapies for pediatric malignancies.
Objectives:
-Systematic Molecular, Genomic, Proteomic, Metabolomic ( Omic ) and other profiling for enrolled subjects.
Eligibility:
Pediatric or Adult subjects of any age with one of the following:
- Diagnosis of any tumor or malignancy, pre-malignant disorder or suspected cancer susceptibility familial syndromes, regardless of age
- Individuals without malignancy undergoing surgery, other treatment or normal well visit.
- Biological relatives of a subject with a pediatric tumor or malignancy or with suspected familial cancer syndrome.
- Patients enrolled in an approved companion protocol
- Blood and/or tissue specimens that have been previously collected and are available for research analysis
- Biospecimens can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care.
Design:
- This study will allow for the collection of specimens for a Tissue Repository, and for designated sample investigations including systematic molecular, genomic and proteomic (Omic) profiling, and growth factor and cellular profile investigations.
Testing activities may include:
- DNA, RNA and protein will be extracted from a section of tumor samples, the remainder will be stored.
- Germ line DNA and RNA will be extracted from lymphocytes or other normal uninvolved tissue
- Germ line DNA will be extracted from lymphocytes or other normal uninvolved tissue of the biological relatives of the subject.
- Xenografts, explant and cell lines established from tumor, pre-malignant and normal samples
- Tumor samples and samples for circulating tumor cells sent for the establishment of Xenografts and single cell suspension of tumor for drug testing
- Omics (Genomics and Proteomic) studies will be performed
- Growth factor and cellular profile investigations of bone marrow-derived cell populations to include quantification of hematopietic progenitor cells (HPCs), endothelial progenitor cells (EPCs), and mesenchymal progenitor cells (MPCs), levels of matrix metalloprotease 2 and 9 (MMP2) and (MMP9), gene expression, growth factor and microvesicle analysis and bone marrow analysis of progenitor cells in blood and tissue.
- Research tests described in active IRB approved protocols
- Immune profiling and stromal profiling of blood, tumor, and normal tissues
- Immune function studies from blood and normal tumor tissues
- Utilizing an oversight committee to oversee the receipt and the distribution of unlinked tissues to other investigators.
- Qualitative methodologies will be used to ascertain knowledge, attitudes, beliefs, and behaviors in 25-35 parents/caregivers at NIH concerning the anticipated use of NGS for diagnosing and directing therapy for pediatric cancer and how incidental findings might be returned.
- Expected accrual 100-150 patients per year.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Donna B Bernstein, R.N.
- Phone Number: (240) 760-6189
- Email: bernsted@mail.nih.gov
Study Contact Backup
- Name: Rosandra N Kaplan, M.D.
- Phone Number: (240) 760-6198
- Email: kaplanrn@mail.nih.gov
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Completed
- Children's National Medical Center
-
-
Florida
-
Orange, Florida, United States, 92613
- Withdrawn
- Children's Hospital of Orange County (CHOC Children's)
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Phone Number: TTY dial 711 800-411-1222
- Email: ccopr@nih.gov
-
-
New York
-
New York, New York, United States, 10029-0574
- Withdrawn
- Tisch Cancer Institute, Mount Sinai Medical Center
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28203
- Withdrawn
- Carolinas Medical Center/Levine Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- SUBJECT INCLUSION CRITERIA:
Pediatric or adult subjects with one of the following:
- Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected premalignant familial syndromes, regardless, of patient age;
- Biological relatives of any patients with tumor, malignancy, premalignant disorder, or suspected familial pre-malignant syndrome, regardless of patient age or the diagnosis of an adult malignancy or pre-malignant disorder;
- Healthy Volunteer without history of malignancy nor a family member currently being treated for cancer who are undergoing surgery, treatment or during well visits;
- Biospecimens can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care.
- Human samples, specimens and data collected on IRB approved protocols that are now closed
- Ability of subject, Legally Authorized Representative (LAR), or parent/legal guardian of children less than or equal to 18 to understand and be willing to sign an IRB-approved informed consent document that permits the use of the tumor and other samples for genomic-based molecular characterization projects.
Inclusion Criteria for Social and Behavioral Outcome Interviews:
- Parent/caregiver of a participating pediatric or adult patient who is being treated for, or who has previously been treated for any form of pediatric cancer.
- Must be able to give consent and sign the informed consent document.
- Able to understand the English language.
EXCLUSION CRITERIA:
None
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
---|
1/Cohort 1
Adult or Pediatric subjects, with any malignancy, pre-malignancy, suspected malignancy, family history of malignancy, or without malignancy undergoing surgery or well visit.
|
2/Cohort 2
Human samples, specimens and data collected on IRB approved protocols that are now closed
|
3/Cohort 3
Parent/caregiver of a participating pediatric or adult subject who is being treated for, or who has previously been treated for any form of pediatric cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tissue analysis
Time Frame: ongoing
|
Perform systematic molecular, genomic, proteomic, metabolomics and other high throughput ( Omics ) profiling on tumor and normal tissues
|
ongoing
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rosandra N Kaplan, M.D., National Cancer Institute (NCI)
Publications and helpful links
General Publications
- Linet MS, Ries LA, Smith MA, Tarone RE, Devesa SS. Cancer surveillance series: recent trends in childhood cancer incidence and mortality in the United States. J Natl Cancer Inst. 1999 Jun 16;91(12):1051-8. doi: 10.1093/jnci/91.12.1051.
- Khan J, Bittner ML, Chen Y, Meltzer PS, Trent JM. DNA microarray technology: the anticipated impact on the study of human disease. Biochim Biophys Acta. 1999 Mar 25;1423(2):M17-28. doi: 10.1016/s0304-419x(99)00004-9.
- Khan J, Saal LH, Bittner ML, Chen Y, Trent JM, Meltzer PS. Expression profiling in cancer using cDNA microarrays. Electrophoresis. 1999 Feb;20(2):223-9. doi: 10.1002/(SICI)1522-2683(19990201)20:23.0.CO;2-A.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Endocrine System Diseases
- Retinal Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Eye Diseases, Hereditary
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Eye Neoplasms
- Retinal Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Sarcoma
- Kidney Neoplasms
- Neuroblastoma
- Retinoblastoma
- Endocrine Gland Neoplasms
Other Study ID Numbers
- 100086
- 10-C-0086
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcoma
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedUterine Corpus Leiomyosarcoma | Stage IIA Uterine Sarcoma | Stage IIB Uterine Sarcoma | Stage IIIA Uterine Sarcoma | Stage IIIB Uterine Sarcoma | Stage IIIC Uterine Sarcoma | Stage IVA Uterine Sarcoma | Stage IVB Uterine Sarcoma | Stage IA Uterine Sarcoma | Stage IB Uterine Sarcoma | Stage IC Uterine SarcomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBone Sarcoma | Retroperitoneal Sarcoma | Adult Soft Tissue SarcomaUnited States
-
Mohammed M MilhemGenentech, Inc.CompletedSarcoma | Soft Tissue Sarcoma | Metastatic Sarcoma | Locally Advanced Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Metastatic Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Synovial Sarcoma | Ewing's Sarcoma | MPNST | High-risk SarcomaUnited States
-
Epizyme, Inc.RecruitingAdvanced Soft-tissue Sarcoma | Advanced Epithelioid SarcomaUnited States, Taiwan, Canada, United Kingdom
-
Brown UniversityActuate Therapeutics Inc.WithdrawnSoft Tissue Sarcoma | Osteosarcoma | Ewing Sarcoma of Bone | Leiomyosarcoma | High Grade Sarcoma | Liposarcoma | Rhabdomyosarcoma | Angiosarcoma | Bone Sarcoma | Synovial Sarcoma | Undifferentiated Pleomorphic Sarcoma | Myxofibrosarcoma | Spindle Cell SarcomaUnited States
-
David DickensWithdrawnSoft Tissue Sarcoma | Bone Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft-tissue Sarcoma | Metastatic Bone Sarcoma | Unresectable Bone SarcomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma