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

NCT01667952 | Completed

• 1 other identifier: 12-143
• Study Type: observational
• Target: 1,068
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric or Young Adult Cancer Survivors

Keywords

Family History Questionnaire (FHQ); Blood sample; Salvia sample; 12-145

Outcome Measures

Primary Outcomes (1)

• establish a registry of DNA

  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

Study Arms (1)

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); Genetic: Salvia sample; Other: Blood sample

Interventions

Family History Questionnaire (FHQ) GENETIC

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.

Cancer Survivors

Salvia sample GENETIC

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.

Cancer Survivors

Blood sample OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Evidence of active progression of disease or recurrence
• Neurocognitive deficits that impair ability to give informed consent.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Danielle Friedman, MD, MS

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 17, 2012
• Study Start: August 1, 2012
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

US (1)