Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT01120353

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Cancer

Study ID

NCT01120353

Start date

Jan 5, 1995

Status verified date

Jun, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

50000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Gregory T. Armstrong, MD, MSCE

888-226-4343referralinfo@stjude.org

Locations

University of Alabama at Birmingham/Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Kimberly Whelan, MD

202-939-9285kwhelan@peds.uab.edu

Principal Investigator:

Kimberly Whelan, MD

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Saro Armenian, DO

626-471-7205sarmenian@coh.org

Principal Investigator:

Saro Armenian, DO

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

David Freyer, DO

323-361-8953DFreyer@chla.usc.edu

Principal Investigator:

David Freyer, DO

University of California-Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Jacqueline Casillas, MD

310-794-2474jcasillas@mednet.ucla.edu

Principal Investigator:

Jacqueline Casillas, MD

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Leonard Sender, MD

714-509-8636lsender@uci.edu

Principal Investigator:

Leonard Sender, MD

University of California-San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Robert Goldsby, MD

415-476-3831goldsbyr@peds.ucsf.edu

Principal Investigator:

Robert Goldsby, MD

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Sheri Spunt, MD

650-723-5535sspunt@stanford.edu

Principal Investigator:

Sheri Spunt, MD

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Brian Greffe, MD

720-777-6787greffe.brian@tchden.org

Principal Investigator:

Robert Greffe, MD

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Jennifer Dean, MD

703-531-3627jdean@psvcare.org

Principal Investigator:

Jennifer Dean, MD

Emory University/Children's Health Care of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Lillian Meacham, MD

404-727-0480lillian.meacham@oz.ped.emory.edu

Principal Investigator:

Lillian Meacham, MD

Ana & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611-2605

Contacts

Jennifer Reichek, MD, MSW

312-227-4777jreichek@luriechildrens.org

Principal Investigator:

Jennifer Reichek, MD, MSW

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Tara Henderson, MD, MPH

773-702-2501

Principal Investigator:

Tara Henderson, MD, MPH

Indiana University/Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Terry Vik, MD

317-944-8784tvik@iupui.edu

Principal Investigator:

Terry Vik, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Lisa Diller, MD

617-632-5642lisa_diller@dfci.harvard.efu

Principal Investigator:

Lisa Diller, MD

University of Michigan/Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Raymond Hutchinson, MD

734-764-7126rhutchin@umich.edu

Principal Investigator:

Raymond Hutchinson, MD

Children's Hospitals & Clinics of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Katharine R. Lange, MD

612-813-6560Katharine.Lange@childrensmn.org

Principal Investigator:

Katharine R. Lange, MD

St. Louis Children's Hospital/The Washington University

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Robert Hayashi, PhD

314-454-4118hayashi_r@kids.wustl.edu

Principal Investigator:

Mark Hayashi, PhD

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Denise Rokitka, MD

716-845-2333denise.rokitka@roswellpark.org

Principal Investigator:

Denise Rokitka, MD

Memorial-Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Danielle Friedman, MD

212-639-8138friedmad@mskcc.org

Principal Investigator:

Danielle Friedman, MD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Randy Olshefski

614-722-3553randal.olshefski@nationwidechildrens.org

Principal Investigator:

Randy Olshefki

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jill Ginsberg, MD

215-590-7399ginsbergji@email.chop.edu

Principal Investigator:

Jill Ginsberg, MD

Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jean Tersak, MD

412-692-5963jean.tersak@chp.edu

Principal Investigator:

Jean Tersak, MD

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Gregory T. Armstrong, MD, MSCE

888-226-4343ccss@stjude.org

Principal Investigator:

Gregory T. Armstrong, MD, MSCE

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Donald Beam, MD

682-885-4007donald.beam@cookchildrens.org

Principal Investigator:

Donald Beam, MD

M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Louise Strong, MD

713-792-2589lstrong@mdanderson.org

Principal Investigator:

Louise Strong, MD

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

ZoAnn E. Dreyer, MD

832-822-4209zdreyer@bcm.edu

Principal Investigator:

ZoAnn E. Dreyer, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Scott Baker, MD

206-884-1018ksbaker@fhcrc.org

Principal Investigator:

Scott Baker, MD

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G-1XB

Contacts

Paul Nathan, MD

416-813-8795paul.nathan@sickkids.ca

Principal Investigator:

Paul Nathan, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • Childhood cancer
  • Young Children
  • Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-06-17.