Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

April 10, 2024 updated by: Children's Oncology Group

Umbrella Long-Term Follow-Up Protocol

This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To develop a mechanism for tracking and retaining patients enrolled on Children's Oncology Group (COG) protocols.

II. To maintain regular, lifetime contact with patients in order to obtain current identification and contact information, and self/parent-reported quality of life and health status.

III. To locate patients who are lost-to-follow-up for COG (or Legacy Group) protocols targeted for follow-up by the Long-Term Follow-Up Center (LTFC).

IV. To provide current patient contact information and self/parent-reported health status updates to the COG Statistics and Data Center (SDC) and to each patient's COG institution.

V. To facilitate collection of protocol-specific outcome data through collaboration with the LTFC Oversight Committee, the SDC, and the member institutions.

OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions.

Within 3 months of enrollment on ALTE05N1, patients receive a packet introducing the Long-Term Follow-Up Center (LTFC). Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients may respond by use of postage prepaid envelopes, secure online form, or 24-hour toll-free telephone number. After initial contact, the LTFC will contact the patient annually.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00912
        • Active, not recruiting
        • San Jorge Children's Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
      • Birmingham, Alabama, United States, 35233
        • Active, not recruiting
        • University of Alabama at Birmingham Cancer Center
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • USA Health Strada Patient Care Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-388-8721
        • Principal Investigator:
          • Hamayun Imran
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Childrens Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 602-546-0920
        • Principal Investigator:
          • Jessica Boklan
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • The University of Arizona Medical Center-University Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 520-626-9008
        • Principal Investigator:
          • Yi Zeng
    • Arkansas
      • Little Rock, Arkansas, United States, 72202-3591
      • Little Rock, Arkansas, United States, 72205
        • Active, not recruiting
        • University of Arkansas for Medical Sciences
    • California
      • Downey, California, United States, 90242
        • Recruiting
        • Kaiser Permanente Downey Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 510-891-3400
        • Principal Investigator:
          • Robert M. Cooper
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Anna B. Pawlowska
      • Loma Linda, California, United States, 92354
        • Suspended
        • Loma Linda University Medical Center
      • Long Beach, California, United States, 90806
        • Recruiting
        • Miller Children's and Women's Hospital Long Beach
        • Principal Investigator:
          • Pamela H. Kempert
        • Contact:
      • Los Angeles, California, United States, 90027
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 310-423-8965
        • Principal Investigator:
          • Fataneh (Fae) Majlessipour
      • Los Angeles, California, United States, 90095
      • Madera, California, United States, 93636
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente-Oakland
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Laura A. Campbell
      • Orange, California, United States, 92868
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital Stanford University
        • Principal Investigator:
          • Sheri L. Spunt
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Marcio H. Malogolowkin
      • San Diego, California, United States, 92123
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Medical Center-Mission Bay
        • Principal Investigator:
          • Robert E. Goldsby
        • Contact:
          • Site Public Contact
          • Phone Number: 877-827-3222
      • San Francisco, California, United States, 94143
        • Active, not recruiting
        • UCSF Medical Center-Parnassus
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
        • Principal Investigator:
          • Jennifer J. Clark
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06106
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Nina S. Kadan-Lottick
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Alfred I duPont Hospital for Children
        • Principal Investigator:
          • Ramamoorthy Nagasubramanian
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 202-444-2223
        • Principal Investigator:
          • Jeffrey A. Toretsky
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • Broward Health Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 954-355-5346
        • Principal Investigator:
          • Hector M. Rodriguez-Cortes
      • Fort Myers, Florida, United States, 33908
      • Fort Myers, Florida, United States, 33901
        • Active, not recruiting
        • Lee Memorial Health System
      • Gainesville, Florida, United States, 32610
        • Active, not recruiting
        • University of Florida Health Science Center - Gainesville
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Clinic-Jacksonville
        • Contact:
        • Principal Investigator:
          • Ramamoorthy Nagasubramanian
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute
        • Contact:
        • Principal Investigator:
          • Doured Daghistani
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Arnold Palmer Hospital for Children
        • Principal Investigator:
          • Don E. Eslin
        • Contact:
      • Orlando, Florida, United States, 32827
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Florida Hospital Orlando
        • Contact:
        • Principal Investigator:
          • Fouad M. Hajjar
      • Orlando, Florida, United States, 32806
        • Active, not recruiting
        • Nemours Children's Clinic - Orlando
      • Orlando, Florida, United States, 32806
        • Active, not recruiting
        • UF Cancer Center at Orlando Health
      • Pensacola, Florida, United States, 32504
        • Active, not recruiting
        • Nemours Children's Clinic - Pensacola
      • Saint Petersburg, Florida, United States, 33701
      • Tampa, Florida, United States, 33607
        • Suspended
        • Saint Joseph's Hospital/Children's Hospital-Tampa
      • West Palm Beach, Florida, United States, 33407
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Recruiting
        • Kapiolani Medical Center for Women and Children
        • Contact:
          • Site Public Contact
          • Phone Number: 808-983-6090
        • Principal Investigator:
          • Wade T. Kyono
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • University of Hawaii Cancer Center
    • Idaho
      • Boise, Idaho, United States, 83712
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Tara O. Henderson
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Mary L. Schmidt
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
        • Principal Investigator:
          • Eugene Suh
      • Oak Lawn, Illinois, United States, 60453
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • Saint Jude Midwest Affiliate
        • Contact:
          • Site Public Contact
          • Phone Number: 888-226-4343
        • Principal Investigator:
          • Jaime M. Libes
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
        • Principal Investigator:
          • Gregory P. Brandt
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
        • Principal Investigator:
          • Kamnesh R. Pradhan
        • Contact:
          • Site Public Contact
          • Phone Number: 800-248-1199
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Saint Vincent Hospital and Health Care Center
        • Contact:
        • Principal Investigator:
          • Bassem I. Razzouk
    • Iowa
      • Des Moines, Iowa, United States, 50309
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
        • Principal Investigator:
          • Mariko Sato
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Principal Investigator:
          • Vlad C. Radulescu
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • Norton Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center Jefferson
        • Contact:
        • Principal Investigator:
          • Craig Lotterman
      • New Orleans, Louisiana, United States, 70112
        • Active, not recruiting
        • Tulane University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Contact:
        • Principal Investigator:
          • Kenneth J. Cohen
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Contact:
        • Principal Investigator:
          • Jason M. Fixler
      • Bethesda, Maryland, United States, 20889-5600
        • Recruiting
        • Walter Reed National Military Medical Center
        • Principal Investigator:
          • Kenneth Lieuw
        • Contact:
          • Site Public Contact
          • Phone Number: 301-319-2100
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Floating Hospital For Children at Tufts Medical Center
        • Principal Investigator:
          • Michael J. Kelly
        • Contact:
          • Site Public Contact
          • Phone Number: 617-636-5535
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension Saint John Hospital
        • Contact:
        • Principal Investigator:
          • Adonis N. Lorenzana
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University/Karmanos Cancer Institute
        • Contact:
        • Principal Investigator:
          • Jeffrey W. Taub
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Helen DeVos Children's Hospital at Spectrum Health
        • Contact:
        • Principal Investigator:
          • Jessica M. Foley
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
        • Principal Investigator:
          • Michael K. Richards
        • Contact:
      • Minneapolis, Minnesota, United States, 55455
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Carola A. Arndt
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Principal Investigator:
          • Gail C. Megason
        • Contact:
          • Site Public Contact
          • Phone Number: 601-815-6700
    • Missouri
      • Columbia, Missouri, United States, 65201
      • Kansas City, Missouri, United States, 64108
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Robert J. Hayashi
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Bethany G. Sleckman
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • University Medical Center of Southern Nevada
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Sunrise Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
      • Las Vegas, Nevada, United States, 89135
        • Recruiting
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Summerlin Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Contact:
        • Principal Investigator:
          • Julie Kim
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Michael B. Harris
        • Contact:
          • Site Public Contact
          • Phone Number: 201-996-2879
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Principal Investigator:
          • Steven L. Halpern
        • Contact:
          • Site Public Contact
          • Phone Number: 973-971-5900
      • New Brunswick, New Jersey, United States, 08901
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-8675
        • Principal Investigator:
          • Richard A. Drachtman
      • Newark, New Jersey, United States, 07112
        • Suspended
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, United States, 07503
      • Summit, New Jersey, United States, 07902
        • Active, not recruiting
        • Overlook Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • John F. Kuttesch
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 518-262-5513
        • Principal Investigator:
          • Lauren R. Weintraub
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Principal Investigator:
          • Lisa Gennarini
        • Contact:
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Denise A. Rokitka
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Winthrop Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 866-946-8476
        • Principal Investigator:
          • Mark E. Weinblatt
      • New York, New York, United States, 10032
        • Recruiting
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Alice Lee
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Pillai Pallavi Madhusoodhan
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Angela R. Girvin
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
        • Principal Investigator:
          • Laura E. Hogan
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Philip M. Monteleone
      • Valhalla, New York, United States, 10595
        • Recruiting
        • New York Medical College
        • Contact:
          • Site Public Contact
          • Phone Number: 914-594-3794
        • Principal Investigator:
          • Jessica C. Hochberg
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Recruiting
        • Mission Hospital Inc-Memorial Campus
        • Contact:
        • Principal Investigator:
          • Douglas J. Scothorn
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Stuart H. Gold
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Presbyterian Medical Center
        • Principal Investigator:
          • Jessica A. Bell
        • Contact:
      • Charlotte, North Carolina, United States, 28203
        • Active, not recruiting
        • Carolinas Medical Center/Levine Cancer Institute
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Susan G. Kreissman
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Contact:
        • Principal Investigator:
          • Andrea R. Whitfield
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • Thomas B. Russell
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cincinnati, Ohio, United States, 45229
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Rabi Hanna
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Rainbow Babies and Childrens Hospital
        • Principal Investigator:
          • John J. Letterio
        • Contact:
          • Site Public Contact
          • Phone Number: 216-844-5437
      • Columbus, Ohio, United States, 43205
      • Dayton, Ohio, United States, 45404
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • The Toledo Hospital/Toledo Children's Hospital
        • Principal Investigator:
          • Jamie L. Dargart
        • Contact:
          • Site Public Contact
          • Phone Number: 419-824-1842
      • Toledo, Ohio, United States, 43608
        • Suspended
        • Mercy Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Rene Y. McNall-Knapp
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Natalie Warren Bryant Cancer Center at Saint Francis
        • Principal Investigator:
          • Gregory B. Kirkpatrick
        • Contact:
          • Site Public Contact
          • Phone Number: 918-494-2200
    • Oregon
      • Portland, Oregon, United States, 97227
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Linda C. Stork
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Suspended
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, United States, 18017
        • Active, not recruiting
        • Lehigh Valley Hospital - Muhlenberg
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19134
      • Pittsburgh, Pennsylvania, United States, 15224
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 401-444-1488
        • Principal Investigator:
          • Jennifer J. Greene Welch
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Jacqueline M. Kraveka
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • Prisma Health Richland Hospital
        • Principal Investigator:
          • Stuart L. Cramer
        • Contact:
          • Site Public Contact
          • Phone Number: 803-434-3533
      • Greenville, South Carolina, United States, 29605
      • Greenville, South Carolina, United States, 29605
        • Active, not recruiting
        • Greenville Cancer Treatment Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Suspended
        • T C Thompson Children's Hospital
      • Knoxville, Tennessee, United States, 37916
        • Recruiting
        • East Tennessee Childrens Hospital
        • Principal Investigator:
          • Ray C. Pais
        • Contact:
          • Site Public Contact
          • Phone Number: 865-541-8266
      • Memphis, Tennessee, United States, 38105
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Debra L. Friedman
    • Texas
      • Austin, Texas, United States, 78723
      • Corpus Christi, Texas, United States, 78411
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Patrick J. Leavey
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Medical City Dallas Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 972-566-5588
        • Principal Investigator:
          • Stanton C. Goldman
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Principal Investigator:
          • ZoAnn E. Dreyer
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
      • San Antonio, Texas, United States, 78207
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Anne-Marie R. Langevin
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • Methodist Children's Hospital of South Texas
    • Utah
      • Salt Lake City, Utah, United States, 84113
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-8990
          • Email: rpo@uvm.edu
        • Principal Investigator:
          • Jessica L. Heath
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Active, not recruiting
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States, 23507
      • Portsmouth, Virginia, United States, 23708-2197
        • Active, not recruiting
        • Naval Medical Center - Portsmouth
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Principal Investigator:
          • Madhu S. Gowda
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98105
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Principal Investigator:
          • Judy L. Felgenhauer
        • Contact:
      • Tacoma, Washington, United States, 98405
      • Tacoma, Washington, United States, 98431
        • Recruiting
        • Madigan Army Medical Center
        • Contact:
        • Principal Investigator:
          • Melissa A. Forouhar
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • West Virginia University Charleston Division
        • Contact:
          • Site Public Contact
          • Phone Number: 304-388-9944
        • Principal Investigator:
          • Ashley E. Meyer
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Principal Investigator:
          • Catherine A. Long
        • Contact:
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Hospital and Clinics
        • Contact:
          • Site Public Contact
          • Phone Number: 800-622-8922
        • Principal Investigator:
          • Kenneth B. De Santes
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Hospital of Wisconsin
        • Contact:
        • Principal Investigator:
          • Paul D. Harker-Murray

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Description

Inclusion Criteria:

  • The patient must reside in the U.S. on the date of enrollment to ALTE05N1
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (long-term follow-up)
Within 3 months of enrollment on ALTE05N1, patients receive a packet introducing the Long-Term Follow-Up Center (LTFC). Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients may respond by use of postage prepaid envelopes, secure online form, or 24-hour toll-free telephone number. After initial contact, the LTFC will contact the patient annually
Procedure: Assessment of Therapy Complications
Complete patient response form and Health Status Update Form
Other: Questionnaire Administration
Complete patient response form, Health Status Update Form (called the "Keep in Touch" form), and Quality of Life Questionnaire (PROMIS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients enrolled
Time Frame: Up to 20 years
Up to 20 years
Percentage of patients in which long-term (20+ years) contact is maintained
Time Frame: Up to 20 years
Up to 20 years
Percentage of eligible patients located who were lost to follow-up
Time Frame: Up to 20 years
Up to 20 years
Percentage of located patients enrolled
Time Frame: Up to 20 years
Differences between participants and non-participants will be examined annually, in terms of demographic (age, sex, ethnicity) and clinical characteristics (primary diagnosis, therapeutic protocol, time since diagnosis, treating institution).
Up to 20 years
Collection of protocol-specific outcome data
Time Frame: Up to 20 years
Methods of statistical analysis to be used are those appropriate for analysis of cohort studies. Poisson regression (piece-wise exponential models) and Cox regression will be the primary methods of risk-factor analysis. When comparing study cohort with national rates, Poisson regression will be used. When the comparison is internal (ie, no use of national standard rates), Cox regression will be used.
Up to 20 years
Collection of cumulative therapeutic exposure data
Time Frame: Up to 20 years
Up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Smita Bhatia, Children's Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2008

Primary Completion (Estimated)

January 31, 2100

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (Estimated)

August 18, 2008

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTE05N1 (Other Identifier: CTEP)
  • U10CA180886 (U.S. NIH Grant/Contract)
  • U10CA098543 (U.S. NIH Grant/Contract)
  • UG1CA189955 (U.S. NIH Grant/Contract)
  • UG1CA189958 (U.S. NIH Grant/Contract)
  • NCI-2009-00382 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • PALTE05N1_A06PAMDREVW01
  • CDR0000590123

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.

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