Childhood Cancer Survivor Study

December 11, 2023 updated by: St. Jude Children's Research Hospital
The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of cancer and its associated therapies. A retrospective cohort study will be conducted through a multi-institutional collaboration, which will involve the identification and active follow-up of a cohort of approximately 50,000 survivors of cancer, diagnosed before 21 years of age, between 1970 and 1999 and 10,000 sibling controls. This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study will focus on the following objectives:

  • Characterize survivors' health with respect to disease- and treatment-related factors.
  • Investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on health outcomes (e.g., cardiovascular, reproductive, second cancers, etc…).
  • Compare the mortality experience of survivors with the general population.
  • Characterize the health-related behaviors, patterns of medical care, and medical follow-up needs of survivors.
  • Describe patterns of familial aggregation of cancer, including known (and variations of) cancer family syndromes.
  • Collect and store biologic samples (saliva, blood, second tumor tissue) to correlate with health outcomes and use for future research.

Study Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

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

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G-1XB
        • Recruiting
        • The Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Paul Nathan, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham/Children's of Alabama
        • Contact:
        • Principal Investigator:
          • Kimberly Whelan, MD
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center
        • Contact:
        • Principal Investigator:
          • Saro Armenian, DO
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Contact:
        • Principal Investigator:
          • David Freyer, DO
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California-Los Angeles
        • Contact:
        • Principal Investigator:
          • Jacqueline Casillas, MD
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
        • Contact:
        • Principal Investigator:
          • Leonard Sender, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California-San Francisco
        • Contact:
        • Principal Investigator:
          • Robert Goldsby, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University School of Medicine
        • Contact:
        • Principal Investigator:
          • Sheri Spunt, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
        • Principal Investigator:
          • Robert Greffe, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Contact:
        • Principal Investigator:
          • Jennifer Dean, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University/Children's Health Care of Atlanta
        • Contact:
        • Principal Investigator:
          • Lillian Meacham, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
          • Tara Henderson, MD, MPH
          • Phone Number: 773-702-2501
        • Principal Investigator:
          • Tara Henderson, MD, MPH
      • Chicago, Illinois, United States, 60611-2605
        • Recruiting
        • Ana & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
        • Principal Investigator:
          • Jennifer Reichek, MD, MSW
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University/Riley Hospital for Children
        • Contact:
        • Principal Investigator:
          • Terry Vik, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Lisa Diller, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan/Mott Children's Hospital
        • Contact:
        • Principal Investigator:
          • Raymond Hutchinson, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Children's Hospitals & Clinics of Minnesota
        • Contact:
        • Principal Investigator:
          • Katharine R. Lange, MD
      • Minneapolis, Minnesota, United States, 55455
        • Completed
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Completed
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Recruiting
        • St. Louis Children's Hospital/The Washington University
        • Contact:
        • Principal Investigator:
          • Mark Hayashi, PhD
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Denise Rokitka, MD
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial-Sloan Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Danielle Friedman, MD
    • Ohio
      • Columbus, Ohio, United States, 43205
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Jill Ginsberg, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Children's Hospital of Pittsburgh
        • Contact:
        • Principal Investigator:
          • Jean Tersak, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital
        • Contact:
          • Gregory T. Armstrong, MD, MSCE
          • Phone Number: 866-278-5833
          • Email: ccss@stjude.org
        • Principal Investigator:
          • Gregory T. Armstrong, MD, MSCE
    • Texas
      • Dallas, Texas, United States, 75390
        • Completed
        • University of Texas Southwestern Medical Center
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Cook Children's Medical Center
        • Contact:
        • Principal Investigator:
          • Donald Beam, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
        • Principal Investigator:
          • ZoAnn E. Dreyer, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • M.D. Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Louise Strong, MD
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
        • Principal Investigator:
          • Scott Baker, MD

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed with cancer between January 1, 1970 and December 31, 1999 at one of the participating centers noted below or identified as sibling control.

Description

Inclusion Criteria:

Initial Cohort:

  • Five-year survival following diagnosis of leukemia, lymphoma, CNS tumor, bone tumor, Wilms tumor, neuroblastoma, or soft tissue sarcoma before age 21 years between January 1, 1970 and December 31, 1986 at one of participating centers.

Expanded cohort:

  • Five-year survival following diagnosis of leukemia, lymphoma, CNS tumor, bone tumor, kidney tumor, neuroblastoma, or rhabdomyosarcoma before age 21 years between January 1, 1987 and December 31, 1999 at one of participating centers.
  • English- or Spanish-speaking and living in the U.S. or Canada at the time of diagnosis.

Exclusion Criteria:

  • Diagnosis of non-malignant tumors (i.e., Langerhans cell histiocytosis, meningioma, craniopharyngioma, etc.) treated with radiation and/or chemotherapy.
  • Non-English speaking or residence outside the US or Canada.

Sibling Controls:

  • For comparison purposes, a group of sibling controls will be identified to represent a stratified random sample based on the distribution of survivors with regard to cancer diagnosis, age, sex, race, and geographic location.

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?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Cancer survivors
Survivors of cancer, diagnosed under 21 years of age, between 1970 and 1999 This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, for an increased risk of late-occurring events associated with excess mortality and morbidity.
Sibling Controls
A group of sibling controls will be identified to provide: (1) the ability to make direct comparisons with the survivors, (2) data on outcomes in a non-cancer population, and (3) additional comparison group to determine consistency of findings between data sources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors.
Time Frame: 25 years
25 years

Collaborators and Investigators

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

Sponsor

St. Jude Children's Research Hospital

Collaborators

M.D. Anderson Cancer Center
National Cancer Institute (NCI)
University of Southern California
University of California, San Francisco
Fred Hutchinson Cancer Center
Nationwide Children's Hospital
Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Gregory T. Armstrong, MD, MSCE, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

January 5, 1995

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (Estimated)

May 10, 2010

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CCSS
  • U24CA055727 (U.S. NIH Grant/Contract)
  • R03CA169150 (U.S. NIH Grant/Contract)
  • R01CA134722 (U.S. NIH Grant/Contract)
  • R01CA136783 (U.S. NIH Grant/Contract)
  • R01CA132899 (U.S. NIH Grant/Contract)
  • R01CA187397 (U.S. NIH Grant/Contract)
  • R01CA175231 (U.S. NIH Grant/Contract)
  • R21CA202210 (U.S. NIH Grant/Contract)
  • R21CA198641 (U.S. NIH Grant/Contract)
  • NCI-2021-05717 (Registry Identifier: NCI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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