Childhood Cancer Survivor Study

Childhood Cancer Survivor Study

Sponsors

Lead sponsor: St. Jude Children's Research Hospital

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

Source St. Jude Children's Research Hospital
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.

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.

Overall Status Recruiting
Start Date January 5, 1995
Completion Date November 2021
Primary Completion Date November 2021
Study Type Observational
Primary Outcome
Measure Time Frame
To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors. 25 years
Enrollment 50000
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

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.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Gregory T. Armstrong, MD, MSCE Principal Investigator St. Jude Children's Research Hospital
Overall Contact

Last name: Gregory T. Armstrong, MD, MSCE

Phone: 1-866-278-5833

Email: [email protected]

Location
facility status contact investigator
University of Alabama at Birmingham/Children's of Alabama | Birmingham, Alabama, 35294, United States Recruiting Kimberly Whelan, MD 202-939-9285 [email protected] Kimberly Whelan, MD Principal Investigator
City of Hope National Medical Center | Duarte, California, 91010, United States Recruiting Saro Armenian, DO 626-471-7205 [email protected] Saro Armenian, DO Principal Investigator
Children's Hospital Los Angeles | Los Angeles, California, 90027, United States Recruiting David Freyer, DO 323-361-8953 [email protected] David Freyer, DO Principal Investigator
University of California-Los Angeles | Los Angeles, California, 90095, United States Recruiting Jacqueline Casillas, MD 310-794-2474 [email protected] Jacqueline Casillas, MD Principal Investigator
Children's Hospital of Orange County | Orange, California, 92868, United States Recruiting Leonard Sender, MD 714-509-8636 [email protected] Leonard Sender, MD Principal Investigator
University of California-San Francisco | San Francisco, California, 94143, United States Recruiting Robert Goldsby, MD 415-476-3831 [email protected] Robert Goldsby, MD Principal Investigator
Stanford University School of Medicine | Stanford, California, 94305, United States Recruiting Sheri Spunt, MD 650-723-5535 [email protected] Sheri Spunt, MD Principal Investigator
Children's Hospital Colorado | Aurora, Colorado, 80045, United States Recruiting Brian Greffe, MD 720-777-6787 [email protected] Robert Greffe, MD Principal Investigator
Children's National Medical Center | Washington, District of Columbia, 20010, United States Recruiting Jennifer Dean, MD 703-531-3627 [email protected] Jennifer Dean, MD Principal Investigator
Emory University/Children's Health Care of Atlanta | Atlanta, Georgia, 30322, United States Recruiting Lillian Meacham, MD 404-727-0480 [email protected] Lillian Meacham, MD Principal Investigator
Ana & Robert H. Lurie Children's Hospital of Chicago | Chicago, Illinois, 60611-2605, United States Recruiting Jennifer Reichek, MD, MSW 312-227-4777 [email protected] Jennifer Reichek, MD, MSW Principal Investigator
University of Chicago | Chicago, Illinois, 60637, United States Recruiting Tara Henderson, MD, MPH 773-702-2501 Tara Henderson, MD, MPH Principal Investigator
Indiana University/Riley Hospital for Children | Indianapolis, Indiana, 46202, United States Recruiting Terry Vik, MD 317-944-8784 [email protected] Terry Vik, MD Principal Investigator
Dana-Farber Cancer Institute | Boston, Massachusetts, 02215, United States Recruiting Lisa Diller, MD 617-632-5642 [email protected] Lisa Diller, MD Principal Investigator
University of Michigan/Mott Children's Hospital | Ann Arbor, Michigan, 48109, United States Recruiting Raymond Hutchinson, MD 734-764-7126 [email protected] Raymond Hutchinson, MD Principal Investigator
Children's Hospitals & Clinics of Minnesota | Minneapolis, Minnesota, 55404, United States Recruiting Katharine R. Lange, MD 612-813-6560 [email protected] Katharine R. Lange, MD Principal Investigator
University of Minnesota | Minneapolis, Minnesota, 55455, United States Recruiting Karim Sadak, MD,MPH,MSE 612-626-2778 [email protected] Karim Sadak, MD,MPH,MSE Principal Investigator
Mayo Clinic | Rochester, Minnesota, 55905, United States Recruiting Vilmarie Rodriguez, MD 507-284-2695 [email protected] Vilmarie Rodriguez, MD Principal Investigator
St. Louis Children's Hospital/The Washington University | Saint Louis, Missouri, 63130, United States Recruiting Robert Hayashi, PhD 314-454-4118 [email protected] Mark Hayashi, PhD Principal Investigator
Roswell Park Cancer Institute | Buffalo, New York, 14263, United States Recruiting Denise Rokitka, MD 716-845-2333 [email protected] Denise Rokitka, MD Principal Investigator
Memorial-Sloan Kettering Cancer Center | New York, New York, 10065, United States Recruiting Danielle Friedman, MD 212-639-8138 [email protected] Danielle Friedman, MD Principal Investigator
Nationwide Children's Hospital | Columbus, Ohio, 43205, United States Recruiting Randy Olshefski 614-722-3553 [email protected] Randy Olshefki Principal Investigator
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, 19104, United States Recruiting Jill Ginsberg, MD 215-590-7399 [email protected] Jill Ginsberg, MD Principal Investigator
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania, 15213, United States Recruiting Jean Tersak, MD 412-692-5963 [email protected] Jean Tersak, MD Principal Investigator
St. Jude Children's Research Hospital | Memphis, Tennessee, 38105, United States Recruiting Gregory T. Armstrong, MD, MSCE 866-278-5833 [email protected] Gregory T. Armstrong, MD, MSCE Principal Investigator
University of Texas Southwestern Medical Center | Dallas, Texas, 75390, United States Recruiting Daniel Bowers, MD 214-648-3150 [email protected] Daniel Bowers, MD Principal Investigator
Cook Children's Medical Center | Fort Worth, Texas, 76104, United States Recruiting Donald Beam, MD 682-885-4007 [email protected] Donald Beam, MD Principal Investigator
M.D. Anderson Cancer Center | Houston, Texas, 77030, United States Recruiting Louise Strong, MD 713-792-2589 [email protected] Louise Strong, MD Principal Investigator
Texas Children's Hospital | Houston, Texas, 77030, United States Recruiting ZoAnn E. Dreyer, MD 832-822-4209 [email protected] ZoAnn E. Dreyer, MD Principal Investigator
Seattle Children's Hospital | Seattle, Washington, 98105, United States Recruiting Scott Baker, MD 206-884-1018 [email protected] Scott Baker, MD Principal Investigator
The Hospital for Sick Children | Toronto, Ontario, M5G-1XB, Canada Recruiting Paul Nathan, MD 416-813-8795 [email protected] Paul Nathan, MD Principal Investigator
Location Countries

Canada

United States

Verification Date

October 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Arm Group

Arm group label: Cancer survivors

Description: 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.

Arm group label: Sibling Controls

Description: 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.

Study Design Info

Observational model: Cohort

Time perspective: Retrospective

Source: ClinicalTrials.gov