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RecruitingObservational

Childhood Cancer Survivor Study

NCT ID: NCT01120353Sponsor: St. Jude Children's Research HospitalLast updated: 2026-06-17

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.

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.

Arms & interventions

Outcome measures

Primary

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

    Time frame: 25 years

Eligibility criteria

Sex: AllAge: All agesHealthy volunteers: Yes
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 locations (30)

University of Alabama at Birmingham/Children's of Alabama

Birmingham, Alabama, 35294

Recruiting
Kimberly Whelan, MD · Contact
Kimberly Whelan, MD · Principal Investigator

City of Hope National Medical Center

Duarte, California, 91010

Recruiting
Saro Armenian, DO · Contact
Saro Armenian, DO · Principal Investigator

Children's Hospital Los Angeles

Los Angeles, California, 90027

Recruiting
David Freyer, DO · Contact
David Freyer, DO · Principal Investigator

University of California-Los Angeles

Los Angeles, California, 90095

Recruiting
Jacqueline Casillas, MD · Contact
Jacqueline Casillas, MD · Principal Investigator

Children's Hospital of Orange County

Orange, California, 92868

Recruiting
Leonard Sender, MD · Contact
Leonard Sender, MD · Principal Investigator

University of California-San Francisco

San Francisco, California, 94143

Recruiting
Robert Goldsby, MD · Contact
Robert Goldsby, MD · Principal Investigator

Stanford University School of Medicine

Stanford, California, 94305

Recruiting
Sheri Spunt, MD · Contact
Sheri Spunt, MD · Principal Investigator

Children's Hospital Colorado

Aurora, Colorado, 80045

Recruiting
Brian Greffe, MD · Contact
Robert Greffe, MD · Principal Investigator

Children's National Medical Center

Washington D.C., District of Columbia, 20010

Recruiting
Jennifer Dean, MD · Contact
Jennifer Dean, MD · Principal Investigator

Emory University/Children's Health Care of Atlanta

Atlanta, Georgia, 30322

Recruiting
Lillian Meacham, MD · Contact
Lillian Meacham, MD · Principal Investigator

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

Chicago, Illinois, 60611-2605

Recruiting
Jennifer Reichek, MD, MSW · Contact
Jennifer Reichek, MD, MSW · Principal Investigator

University of Chicago

Chicago, Illinois, 60637

Recruiting
Tara Henderson, MD, MPH · Contact
Tara Henderson, MD, MPH · Principal Investigator

Indiana University/Riley Hospital for Children

Indianapolis, Indiana, 46202

Recruiting
Terry Vik, MD · Contact
Terry Vik, MD · Principal Investigator

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Lisa Diller, MD · Principal Investigator

University of Michigan/Mott Children's Hospital

Ann Arbor, Michigan, 48109

Recruiting
Raymond Hutchinson, MD · Contact
Raymond Hutchinson, MD · Principal Investigator

Children's Hospitals & Clinics of Minnesota

Minneapolis, Minnesota, 55404

Recruiting
Katharine R. Lange, MD · Contact
Katharine R. Lange, MD · Principal Investigator

University of Minnesota

Minneapolis, Minnesota, 55455

Completed

Mayo Clinic

Rochester, Minnesota, 55905

Completed

St. Louis Children's Hospital/The Washington University

St Louis, Missouri, 63130

Recruiting
Robert Hayashi, PhD · Contact
Mark Hayashi, PhD · Principal Investigator

Roswell Park Cancer Institute

Buffalo, New York, 14263

Recruiting
Denise Rokitka, MD · Contact
Denise Rokitka, MD · Principal Investigator

Memorial-Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Danielle Friedman, MD · Contact
Danielle Friedman, MD · Principal Investigator

Nationwide Children's Hospital

Columbus, Ohio, 43205

Recruiting
Randy Olshefki · Principal Investigator

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Recruiting
Jill Ginsberg, MD · Contact
Jill Ginsberg, MD · Principal Investigator

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213

Recruiting
Jean Tersak, MD · Contact
Jean Tersak, MD · Principal Investigator

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

Recruiting
Gregory T. Armstrong, MD, MSCE · Contact
Gregory T. Armstrong, MD, MSCE · Principal Investigator

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Completed

Cook Children's Medical Center

Fort Worth, Texas, 76104

Recruiting
Donald Beam, MD · Principal Investigator

M.D. Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Louise Strong, MD · Contact
Louise Strong, MD · Principal Investigator

Texas Children's Hospital

Houston, Texas, 77030

Recruiting
ZoAnn E. Dreyer, MD · Contact
ZoAnn E. Dreyer, MD · Principal Investigator

Seattle Children's Hospital

Seattle, Washington, 98105

Recruiting
Scott Baker, MD · Contact
Scott Baker, MD · Principal Investigator

References

  • Webster R, Chambers EO, Qiu W, Dhaduk R, Wang L, Yasui Y, Yuan Y, Nathan PC, Leisenring W, Armstrong GT, Howell R, Schulte T, Yalch M, Cordova M, Krull KR, Brinkman TM, Edelstein K. Neurocognitive impairment and substance use in adult survivors of childhood cancer: a cross-sectional analysis from the Childhood Cancer Survivor Study. EClinicalMedicine. 2026 Apr 29;95:103924. doi: 10.1016/j.eclinm.2026.103924. eCollection 2026 May.(PubMed)
  • 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;61(7):163117. doi: 10.1016/j.jpedsurg.2026.163117. Online ahead of print.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)