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Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01667952
First received: August 15, 2012
Last updated: November 10, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to establish a registry of survivors of cancer, tumor, or a related illness.


Condition Intervention
Pediatric or Young Adult Cancer Survivors
Genetic: Family History Questionnaire (FHQ) and Saliva or blood samples

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • establish a registry of DNA [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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

Saliva or blood samples will be collected in the clinic at the time of a routine visit.


Estimated Enrollment: 1000
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cancer Survivors
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) and Saliva or blood samples
Consented subjects will be given the Family History Questionnaire (FHQ) (Appendix A), to complete either in clinic or at home. For participants who are children and can not fill out the questionnaire on their own, the clinic RSA will instruct the parent or guardian present to fill out the questionnaire, reminding them that the "You" in the questionnaire refers to their child. Saliva or blood samples will be collected in the clinic at the time of a routine visit. The patient will decide which type of sample they would like to donate. For children who are ten years of age or younger, who cannot be expected to produce a saliva sample, approximately 3-5cc of blood will be collected.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from the Adult Long-Term Follow-Up Program, the Pediatric Long Term Follow-up Program, or Lymphoma Service will be recruited at a routine visit to MSKCC.

Criteria

Inclusion Criteria:

  • English speaking
  • A personal history of cancer tumor, or a related illness
  • Followed in the the Adult Long Term Follow Up Program, Pediatric Long Term Follow Up Program, or Lymphoma Service at MSKCC

Exclusion Criteria:

  • Evidence of active progression of disease or recurrence
  • Neurocognitive deficits that impair ability to give informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667952

Contacts
Contact: Emily Tonorezos, MD, MPH 646-888-4730
Contact: Ken Offit, MD 646-888-4050

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Emily Tonorezos, MD,MPH    646-888-4730      
Contact: Kenneth Offit, MD    646-888-4050      
Principal Investigator: Emily Tonorezos, MD, MPH         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Emily Tonorezos, MD, MPH Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01667952     History of Changes
Other Study ID Numbers: 12-143
Study First Received: August 15, 2012
Last Updated: November 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Family History Questionnaire (FHQ)
Blood sample
Salvia sample
12-145

ClinicalTrials.gov processed this record on November 27, 2014