NCT01120353

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jan 1995

Longer than P75 for all trials

Geographic Reach
2 countries

31 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jan 1995Nov 2026

Study Start

First participant enrolled

January 5, 1995

Completed
15.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

31.8 years

First QC Date

May 6, 2010

Last Update Submit

April 23, 2026

Conditions

Cancer

Keywords

Childhood cancerYoung ChildrenAdults

Outcome Measures

Primary Outcomes (1)

  • To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors.

    25 years

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

University of Alabama at Birmingham/Children's of Alabama

Birmingham, Alabama, 35294, United States

RECRUITING

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

University of California-Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Children's Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

University of California-San Francisco

San Francisco, California, 94143, United States

RECRUITING

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Children's National Medical Center

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

RECRUITING

Emory University/Children's Health Care of Atlanta

Atlanta, Georgia, 30322, United States

RECRUITING

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

Chicago, Illinois, 60611-2605, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Indiana University/Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan/Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

Children's Hospitals & Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

COMPLETED

Mayo Clinic

Rochester, Minnesota, 55905, United States

COMPLETED

St. Louis Children's Hospital/The Washington University

St Louis, Missouri, 63130, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Memorial-Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

COMPLETED

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

RECRUITING

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G-1XB, Canada

RECRUITING

Related Publications (7)

  • Murphy AJ, Chen Y, Cameron DB, Geiger EJ, Ramsey D, Green DM, Howell RM, Kieran K, Krull KR, Meacham LR, Ness KK, Oeffinger KC, Yasui Y, Armstrong GT, Chow EJ, Weldon CB, Weil BR. Late complications of treatment for childhood pelvic sarcoma: A report from the Childhood Cancer Survivor Study (CCSS). J Pediatr Surg. 2026 Mar 30:163117. doi: 10.1016/j.jpedsurg.2026.163117. Online ahead of print.

    PMID: 41921603DERIVED

  • Alberts NM, Leisenring W, Whitton J, Stratton K, Jibb L, Flynn J, Pizzo A, Brinkman TM, Birnie K, Gibson TM, McDonald A, Ford J, Olgin JE, Nathan PC, Stinson JN, Armstrong GT. Characterization of chronic pain, pain interference, and daily pain experiences in adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Pain. 2024 Nov 1;165(11):2530-2543. doi: 10.1097/j.pain.0000000000003284. Epub 2024 Jul 9.

    PMID: 38981063DERIVED

  • Wilson CL, Bjornard KL, Partin RE, Kadan-Lottick NS, Nathan PC, Oeffinger KC, Hayashi RJ, Hyun G, Armstrong GT, Leisenring WM, Howell RM, Yasui Y, Dixon SB, Ehrhardt MJ, Robison LL, Ness KK. Trends in physical functioning in acute lymphoblastic leukemia and non-Hodgkin lymphoma survivors across three decades. J Cancer Surviv. 2025 Apr;19(2):496-506. doi: 10.1007/s11764-023-01483-1. Epub 2023 Nov 8.

    PMID: 37938431DERIVED

  • Chen C, Qin N, Wang M, Dong Q, Tithi SS, Hui Y, Chen W, Wu G, Kennetz D, Edmonson MN, Rusch MC, Thrasher A, Easton J, Mulder HL, Song N, Plonski NM, Shelton K, Im C, Ehrhardt MJ, Nichols KE, Leisenring WM, Stratton KL, Howell R, Yasui Y, Bhatia S, Armstrong GT, Ness KK, Hudson MM, Zhang J, Wang H, Srivastava DK, Robison LL, Wang Z. Cancer germline predisposing variants and late mortality from subsequent malignant neoplasms among long-term childhood cancer survivors: a report from the St Jude Lifetime Cohort and the Childhood Cancer Survivor Study. Lancet Oncol. 2023 Oct;24(10):1147-1156. doi: 10.1016/S1470-2045(23)00403-5.

    PMID: 37797633DERIVED

  • Mulrooney DA, Hyun G, Ness KK, Ehrhardt MJ, Yasui Y, Duprez D, Howell RM, Leisenring WM, Constine LS, Tonorezos E, Gibson TM, Robison LL, Oeffinger KC, Hudson MM, Armstrong GT. Major cardiac events for adult survivors of childhood cancer diagnosed between 1970 and 1999: report from the Childhood Cancer Survivor Study cohort. BMJ. 2020 Jan 15;368:l6794. doi: 10.1136/bmj.l6794.

    PMID: 31941657DERIVED

  • Ness KK, Hudson MM, Jones KE, Leisenring W, Yasui Y, Chen Y, Stovall M, Gibson TM, Green DM, Neglia JP, Henderson TO, Casillas J, Ford JS, Effinger KE, Krull KR, Armstrong GT, Robison LL, Oeffinger KC, Nathan PC. Effect of Temporal Changes in Therapeutic Exposure on Self-reported Health Status in Childhood Cancer Survivors. Ann Intern Med. 2017 Jan 17;166(2):89-98. doi: 10.7326/M16-0742. Epub 2016 Nov 8.

    PMID: 27820947DERIVED

  • Patterson BC, Chen Y, Sklar CA, Neglia J, Yasui Y, Mertens A, Armstrong GT, Meadows A, Stovall M, Robison LL, Meacham LR. Growth hormone exposure as a risk factor for the development of subsequent neoplasms of the central nervous system: a report from the childhood cancer survivor study. J Clin Endocrinol Metab. 2014 Jun;99(6):2030-7. doi: 10.1210/jc.2013-4159. Epub 2014 Feb 25.

    PMID: 24606096DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva and second tumor specimens

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Gregory T. Armstrong, MD, MSCE

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory T. Armstrong, MD, MSCE

CONTACT

888-226-4343referralinfo@stjude.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 10, 2010

Study Start

January 5, 1995

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

CA(1)US(30)