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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

August 15, 2012
November 10, 2014
August 2012
August 2016   (final data collection date for primary outcome measure)
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.
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 cancer survivors. 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.
Complete list of historical versions of study NCT01667952 on ClinicalTrials.gov Archive Site
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Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness
Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness

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

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Observational
Observational Model: Family-Based
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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.

Pediatric or Young Adult Cancer Survivors
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.
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.
Intervention: Genetic: Family History Questionnaire (FHQ) and Saliva or blood samples
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
August 2016
August 2016   (final data collection date for primary outcome measure)

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.
Both
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No
Contact: Emily Tonorezos, MD, MPH 646-888-4730
Contact: Ken Offit, MD 646-888-4050
United States
 
NCT01667952
12-143
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Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Emily Tonorezos, MD, MPH Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP