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CancerNCT01120353

Childhood Cancer Survivor Study

An observational study of Cancer, run by St. Jude Children's Research Hospital at 31 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Cancer
How many people
50,000 participants
Where
31 sitesin 2 countries
Study dates
5 Jan 1995to Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

31 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Gregory T. Armstrong, MD, MSCE contact

888-226-4343

referralinfo@stjude.org

31 sites in 2 countries

United States30 sites, 27 recruiting

  • University of Michigan/Mott Children's Hospital

    Ann Arbor, Michigan, 48109

    Raymond Hutchinson, MD, 734-764-7126, rhutchin@umich.edu

    Raymond Hutchinson, MD

    Recruiting

  • Emory University/Children's Health Care of Atlanta

    Atlanta, Georgia, 30322

    Lillian Meacham, MD, 404-727-0480, lillian.meacham@oz.ped.emory.edu

    Lillian Meacham, MD

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Brian Greffe, MD, 720-777-6787, greffe.brian@tchden.org

    Robert Greffe, MD

    Recruiting

  • University of Alabama at Birmingham/Children's of Alabama

    Birmingham, Alabama, 35294

    Kimberly Whelan, MD, 202-939-9285, kwhelan@peds.uab.edu

    Kimberly Whelan, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Lisa Diller, MD, 617-632-5642, lisa_diller@dfci.harvard.efu

    Lisa Diller, MD

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Denise Rokitka, MD, 716-845-2333, denise.rokitka@roswellpark.org

    Denise Rokitka, MD

    Recruiting

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

    Chicago, Illinois, 60611-2605

    Jennifer Reichek, MD, MSW, 312-227-4777, jreichek@luriechildrens.org

    Jennifer Reichek, MD, MSW

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Tara Henderson, MD, MPH, 773-702-2501

    Tara Henderson, MD, MPH

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Randy Olshefski, 614-722-3553, randal.olshefski@nationwidechildrens.org

    Randy Olshefki

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Completed

  • City of Hope National Medical Center

    Duarte, California, 91010

    Saro Armenian, DO, 626-471-7205, sarmenian@coh.org

    Saro Armenian, DO

    Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

    Donald Beam, MD, 682-885-4007, donald.beam@cookchildrens.org

    Donald Beam, MD

    Recruiting

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

    Louise Strong, MD, 713-792-2589, lstrong@mdanderson.org

    Louise Strong, MD

    Recruiting

  • Texas Children's Hospital

    Houston, Texas, 77030

    ZoAnn E. Dreyer, MD, 832-822-4209, zdreyer@bcm.edu

    ZoAnn E. Dreyer, MD

    Recruiting

  • Indiana University/Riley Hospital for Children

    Indianapolis, Indiana, 46202

    Terry Vik, MD, 317-944-8784, tvik@iupui.edu

    Terry Vik, MD

    Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

    David Freyer, DO, 323-361-8953, DFreyer@chla.usc.edu

    David Freyer, DO

    Recruiting

  • University of California-Los Angeles

    Los Angeles, California, 90095

    Jacqueline Casillas, MD, 310-794-2474, jcasillas@mednet.ucla.edu

    Jacqueline Casillas, MD

    Recruiting

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

    Gregory T. Armstrong, MD, MSCE, 888-226-4343, ccss@stjude.org

    Gregory T. Armstrong, MD, MSCE

    Recruiting

  • Children's Hospitals & Clinics of Minnesota

    Minneapolis, Minnesota, 55404

    Katharine R. Lange, MD, 612-813-6560, Katharine.Lange@childrensmn.org

    Katharine R. Lange, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Completed

  • Memorial-Sloan Kettering Cancer Center

    New York, New York, 10065

    Danielle Friedman, MD, 212-639-8138, friedmad@mskcc.org

    Danielle Friedman, MD

    Recruiting

  • Children's Hospital of Orange County

    Orange, California, 92868

    Leonard Sender, MD, 714-509-8636, lsender@uci.edu

    Leonard Sender, MD

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Jill Ginsberg, MD, 215-590-7399, ginsbergji@email.chop.edu

    Jill Ginsberg, MD

    Recruiting

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

    Jean Tersak, MD, 412-692-5963, jean.tersak@chp.edu

    Jean Tersak, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Completed

  • University of California-San Francisco

    San Francisco, California, 94143

    Robert Goldsby, MD, 415-476-3831, goldsbyr@peds.ucsf.edu

    Robert Goldsby, MD

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Scott Baker, MD, 206-884-1018, ksbaker@fhcrc.org

    Scott Baker, MD

    Recruiting

  • St. Louis Children's Hospital/The Washington University

    St Louis, Missouri, 63130

    Robert Hayashi, PhD, 314-454-4118, hayashi_r@kids.wustl.edu

    Mark Hayashi, PhD

    Recruiting

  • Stanford University School of Medicine

    Stanford, California, 94305

    Sheri Spunt, MD, 650-723-5535, sspunt@stanford.edu

    Sheri Spunt, MD

    Recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    Jennifer Dean, MD, 703-531-3627, jdean@psvcare.org

    Jennifer Dean, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • The Hospital for Sick Children

    Toronto, Ontario, M5G-1XB

    Paul Nathan, MD, 416-813-8795, paul.nathan@sickkids.ca

    Paul Nathan, MD

    Recruiting

Other trials in Canada

About this study

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.

Read the 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.
Conditions
Cancer
Keywords
Childhood cancer, Young Children, Adults
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01120353
Study groupRoleWhat they receive
Cancer survivorsSurvivors 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 ControlsA 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 being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 25 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2010 (estimated)
  2. Study start5 Jan 1995
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
50,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01120353
Sponsor's protocol ID
CCSS
Other IDs
U24CA055727, R03CA169150, R01CA134722, R01CA136783, R01CA132899, R01CA187397, R01CA175231, R21CA202210
Status last verified
Jun 2026
First submitted
6 May 2010
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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 42094234

  • 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 Jul;61(7):163117. doi: 10.1016/j.jpedsurg.2026.163117. Epub 2026 Mar 30.

    PubMed 41921603

  • Bashore L, Peterson RK, Li C, Liu W, Wang M, Jiwani ZM, McDonald AJ, Lupo PJ, King A, Srivastava D, Leisenring WM, Howell RM, Gibson TM, Oeffinger K, Armstrong GT, Bowman WP, Krull KR, Edelstein K. Chronic Health Conditions and Academic Achievement: A Childhood Cancer Survivor Study Report. JCO Oncol Pract. 2026 Jul;22(7):1322-1330. doi: 10.1200/OP-25-00414. Epub 2025 Sep 8.

    PubMed 40920992

  • 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 38981063

  • 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 37938431

  • 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 37797633

  • 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 31941657

  • 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 27820947

  • 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 24606096

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by St. Jude Children's Research Hospital at 31 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gregory T. Armstrong, MD, MSCE (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors. (time frame: 25 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01120353, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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