Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness
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|ClinicalTrials.gov Identifier: NCT01667952|
Recruitment Status : Recruiting
First Posted : August 17, 2012
Last Update Posted : September 9, 2020
|Condition or disease||Intervention/treatment|
|Pediatric or Young Adult Cancer Survivors||Genetic: Family History Questionnaire (FHQ) Genetic: Salvia sample Other: Blood sample|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
The purpose of this study is to establish a registry of survivors of cancer, tumors,or a related illness. The registry will include detailed family history and germline DNA. Ultimately, we hope to improve our understanding of genetic susceptibility to secondary malignant neoplasms and other late effects among survivors of cancer, tumors, or a related illness.
Genetic: Family History Questionnaire (FHQ)
Consented subjects will be given the Family History Questionnaire (FHQ) to complete either in clinic or at home. Subjects who chose to complete the FHQ at home will be given a stamped envelope with a label. For participants who are children and cannot fill out the questionnaire on their own, the clinic RSA will instruct the parent, guardian, or legally authorized representative (LAR) present to fill out the questionnaire, reminding them that the "You" in the questionnaire refers to their child.
Genetic: Salvia sample
The saliva samples will be collected in Oragene DNA Self-Collection Kits or a similar product. Patients will be instructed to donate about 2ml of saliva into a vial, which contains 2ml of product. Oragene or similar solution.
Other: Blood sample
Subjects will be offered the option of a blood collection instead of saliva. For adult subjects who opt for blood collection, two tubes of blood (approximately 20cc) will be drawn from the utilizing a sterile technique. For subjects under the age of 18 who opt for blood collection, approximately 3-5cc of blood will be collected utilizing a sterile technique.
- establish a registry of DNA [ Time Frame: 4 years ]For the purpose of facilitating future genetic laboratory investigations of late effects among of survivors of cancer, tumors, or a related illness. Patients in the ALTFU Program are followed for secondary malignant neoplasms and other adverse outcomes (so-called "late effects") including cardiomyopathy, pulmonary fibrosis, cardiac valvular pathology, osteoporosis, and others. The following data will be ascertained from each study participant: (1) family history information will be ascertained using the Family History Questionnaire (Appendix A); and (2) saliva or blood samples for genetic analysis.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667952
|Contact: Danielle Friedman, MD, MS||212-639-7376|
|Contact: Ken Offit, MD||646-888-4050|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Danielle Friedman, MD,MS 212-639-7376|
|Contact: Kenneth Offit, MD 646-888-4050|
|Principal Investigator: Danielle Friedman, MD, MS|
|Principal Investigator:||Danielle Friedman, MD, MS||Memorial Sloan Kettering Cancer Center|