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

March 6, 2025 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to establish a registry of survivors of cancer, tumor, or a related illness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1068

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Family-Based
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 6, 2025

Study Completion (Actual)

March 6, 2025

Study Registration Dates

First Submitted

August 15, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimated)

August 17, 2012

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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