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Childhood Cancer Survivor Study


Active: Yes
Cancer Type: Brain & Spinal Cord Tumor
Hodgkin Lymphoma
Leukemia
Lymphoma
Neuroblastoma
Non-Hodgkin Lymphoma
Solid Tumor
NCT ID: NCT01120353
Trial Phases: Protocol IDs: CCSS (primary)
U24CA055727
Eligibility: 0 - 21 Years, Male and Female Study Type: Other
Study Sponsor: Saint Jude Children's Research Hospital
NCI Full Details: http://clinicaltrials.gov/show/NCT01120353

Summary

This study collects biospecimen samples and health information to investigate the long-term effects of cancer and its associated therapies. This study may help researchers understand more about what may cause a person to develop more than one tumor. The study may help researchers find out more information about how cancers grow, why cancer responds to some treatment and not others, and what causes cancer cells to become different from cells in healthy tissue.

Objectives

PRIMARY OBJECTIVES:
I. Compare the mortality experience of survivors with the general population, particularly during the third and fourth decades of life. (Initial Cohort [1970-1986])
II. Provide additional data on the known treatment- and disease-related factors associated with an increased risk of subsequent cancers, and:
IIa. Documenting changes in the site and histologic distributions of second cancers as the interval from initial diagnosis/treatment increases. (Initial Cohort [1970-1986])
IIb. Identifying new associations between the risk of second cancers and initial cancer diagnosis, treatment factors (e.g., more intensive treatment programs), and family history. (Initial Cohort [1970-1986])
IIc. Proposing specific groups of survivors who, because of their increased risk, should be enrolled in programs for cancer prevention and early detection. (Initial Cohort [1970-1986])
IId. Providing data, for use in the design of future cancer treatment protocols, on specific treatment approaches which provide the lowest risk for second cancers. (Initial Cohort [1970-1986])
III. Better describe the long-term cardiopulmonary toxicity in survivors exposed to chemotherapy and radiation by:
IIIa. Supplying more detailed information on the incidence and risk factors for symptomatic cardiac or pulmonary disease. (Initial Cohort [1970-1986])
IIIb. Quantifying the risk associated with interactions between radiation and specific chemotherapeutic agents (Initial Cohort [1970-1986])
IIIc. Examining the possibility that treatment-related factors may result in an earlier onset of “classical” adult cardiovascular disease (e.g., coronary artery disease). (Initial Cohort [1970-1986])
IIId. Valuating the influence of environmental exposures, such as tobacco smoke, on the occurrence of cardiopulmonary disease. (Initial Cohort [1970-1986])
IV. Further investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on reproduction, and:
IVa. Quantifying the risk for adverse reproductive factors associated with treatment, age at exposure, type of cancer, and sex. (Initial Cohort [1970-1986])
IVb. Determining the overall, age, sex, diagnosis, and therapy-specific fertility of survivors (Initial Cohort [1970-1986])
IVc. Documenting the incidence of, and risk factors for, symptomatic gonadal failure and subsequent sequelae. (Initial Cohort [1970-1986])
IVd. Establishing the risk for adverse pregnancy outcomes including recognized spontaneous abortion, low birth weight, and congenital anomalies, in order to develop a profile of high-risk pregnancies where specific recommendations can be made for preconception counseling, as well as pre and peri-natal care. (Initial Cohort [1970-1986])
V. Describe patterns of familial aggregation of cancer, including known (and variations of) cancer family syndromes, to:
Va. Provide additional information on the genetics of cancers. (Initial Cohort [1970-1986])
Vb. Establish estimates of risk to family members for use in genetic counseling and primary and secondary cancer prevention. (Initial Cohort [1970-1986])
Vc. Identify family members in whom molecular genetic studies may yield valuable new information. (Initial Cohort [1970-1986])
VI. Characterize the health-related behaviors and patterns of medical care of survivors to use in the development of primary and secondary prevention strategies, as well as assessing the medical follow-up needs of this population. (Initial Cohort [1970-1986])
VII. The cohort will be of sufficient size and heterogeneity with respect to the type of childhood cancer and exposure to radiation, chemotherapeutic agents, and/or surgery to allow for the study of endpoints of interest in this population. Specific risk factors of interest include: (i) original diagnosis; (ii) intensity and duration of exposure to therapeutic radiation and chemotherapeutic agents; (iii) patient characteristics such as sex and age at exposure; and (iv) genetic factors as measured by family history and type of childhood cancer. (Initial Cohort [1970-1986])
VIII. Maintain the strong and productive resource of the e Childhood Cancer Survivor Study (CCSS) through continued follow-up of the initial population, diagnosed between 1970-86. (Initial Cohort [1970-1986])
IX. Systematically ascertain and characterize the occurrence of health-related outcomes and quality of life outcomes. (Initial Cohort [1970-1986])
X. Make available genomic deoxyribonucleic acid (DNA) to allow the study of genetic susceptibility and gene-therapy exposure interaction. (Initial Cohort [1970-1986])
XI. Continue to trace and recruit survivors who were previously considered to be lost-to-follow-up among participant who have a signed Health Insurance Portability and Accountability Act (HIPAA) release on file. (Initial Cohort [1970-1986])
XII. Continue to validate all subsequent cancers, collect and store tumor specimens, and collect peripheral blood samples and establish lymphoblastoid cell lines for survivors with subsequent neoplasms. (Initial Cohort [1970-1986])
XIII. Identify high-risk populations to aid in future cancer control activities including the design and testing of prevention, early detection and behavioral/ therapeutic interventions intended to lower risk. (Initial Cohort [1970-1986])
XIV. Enhance the resource by recruiting individuals diagnosed between 1987-99. (Expanded Cohort [1987-1999])
XIVa. Recruit and follow an additional 14,800 five-year survivors, selected in a manner that will over-sample those treated with regimens that differ from the initial population, and among ethnic/racial minorities. (Expanded Cohort [1987-1999])
XIVb. Collect selected baseline and follow-up outcome information comparable to the initial survivor population. (Expanded Cohort [1987-1999])
XIVc. Enroll 4000 siblings of survivors, selected from the pool of siblings within the expanded population. (Expanded Cohort [1987-1999])
XIVd. Extensively characterize survivors with respect to disease- and treatment-related factors. (Expanded Cohort [1987-1999])
XIVe. Collect and store buccal cell samples as a source of genomic DNA from survivors and sibling controls. (Expanded Cohort [1987-1999])
XIVf. Ascertain and validate all subsequent cancers, collect and store tumor specimens, and collect peripheral blood and establish lymphoblastoid cell lines for survivors with subsequent neoplasms. (Expanded Cohort [1987-1999])
XIVg. Determine vital status, cause of death and evaluate demographic and treatment-related risk factors for mortality among all survivors eligible for participation. (Expanded Cohort [1987-1999])

OUTLINE:
Patients complete questionnaires over 35-45 minutes at baseline then every 2 years. Their medical records are reviewed, retrospectively. Patients undergo blood and buccal cell sample collection, and remaining tissue samples from collected at previous surgery are also collected.

After completion of the study, participants are followed up after 3 years.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

Study Coordinator:
Sindy Midoro
Doctors:


Aflac Cancer and Blood Disorders Center of Children’s at Scottish Rite
5455 Meridian Mark Road
Suite 400
Atlanta, GA 30342
404-785-2215
www.choa.org

Study Coordinator:
Sindy Midoro
Doctors:

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.