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 July 2015 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: July 13, 2015
Last verified: July 2015

August 15, 2012
July 13, 2015
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.

Not Provided
Observational
Observational Model: Family-Based
Time Perspective: Prospective
Not Provided
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)
    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.
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.
Interventions:
  • Genetic: Family History Questionnaire (FHQ)
  • Genetic: Salvia sample
  • Other: Blood sample
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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 646-888-8080
Contact: Ken Offit, MD 646-888-4050
United States
 
NCT01667952
12-143
Not Provided
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
July 2015

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