Clinical trial NCT01120353: Childhood Cancer Survivor Study
Official title: Childhood Cancer Survivor Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Childhood cancer
Young Children
Adults
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Fred Hutchinson Cancer Center
name: Nationwide Children's Hospital
name: M.D. Anderson Cancer Center
name: University of Southern California
name: Children's Hospital Medical Center, Cincinnati
name: University of California, San Francisco
First posted: 2010-05-10
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

Eligibility 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.

Primary outcomes:
measure: To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors.
timeFrame: 25 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham/Children's of Alabama
state: Alabama
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of California-Los Angeles
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: San Francisco
country: United States
facility: University of California-San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University/Children's Health Care of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Ana & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University/Riley Hospital for Children
state: Indiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan/Mott Children's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Children's Hospitals & Clinics of Minnesota
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital/The Washington University
state: Missouri
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial-Sloan Kettering Cancer Center
state: New York
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Gregory T. Armstrong, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.