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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01667952
Collaborator
(none)
1,068
1
132
8.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Genetic: Family History Questionnaire (FHQ)
  • Genetic: Salvia sample
  • Other: Blood sample

Study Design

Study Type:
Observational
Actual Enrollment :
1068 participants
Observational Model:
Family-Based
Time Perspective:
Prospective
Official Title:
Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness
Study Start Date :
Aug 1, 2012
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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)
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.

Outcome Measures

Primary Outcome Measures

  1. establish a registry of DNA [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Danielle Friedman, MD, MS, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01667952
Other Study ID Numbers:
  • 12-143
First Posted:
Aug 17, 2012
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Keywords provided by Memorial Sloan Kettering Cancer Center

Study Results

No Results Posted as of Oct 7, 2021