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NCT02665195 Clinical Trial

Prospective Registry of Multiplex Testing (PROMPT)

Genetic Testing Clinical Trial

Official title:
Prospective Registry of Multiplex Testing (PROMPT): Phase II

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02665195
Other study ID # 16-017
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2016
Est. completion date January 2025

Study information
Verified date February 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study is being done to learn more about how changes in certain genes may be linked to cancer. Some people with cancer got their disease because they inherited an abnormal (mutated) gene. The researchers of this study want to better understand the risks that are linked to genetic changes in these less well-studied genes. By understanding these risks, we believe that doctors will be able to give better advice to families with mutations in these genes.

Description:

PROMPT (Prospective Registry of Multiplex Testing) is an Internet-based, patient-directed ascertainment study. It is a partnership between Memorial Sloan Kettering, University of Pennsylvania, Mayo Clinic, and Dana Farber Cancer Institute in collaboration with Ambry Genetics, GeneDx, Myriad Genetics, Pathway Genomics, and Quest Laboratories (5 laboratories providing multiplex panel testing commercially).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 689
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Individual with deleterious (pathogenic) or likely deleterious (likely pathogenic) mutation in a cancer susceptibility gene OR - Individual with a variant of uncertain significance (VUS) in a cancer susceptibility gene OR - Family members, either tested or not tested, who are part of a family known to be transmitting a deleterious or likely deleterious mutation or a variant of uncertain significance in a cancer predisposition gene Exclusion Criteria: - Inability or refusal to participate in consent discussion - Subject is less than 18 years old

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• saliva specimen

Behavioral:
• questionnaire

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Dana Farber Cancer Institute Boston Massachusetts
United States Memorial Sloan Kettering Cancer Center @ Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States University of Pennsylvania Philadelphia Pennsylvania
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Memorial Sloan Kettering @ Rockville Rockville Centre New York

Sponsors (4)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Dana-Farber Cancer Institute, Mayo Clinic, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acquire DNA samples 3 years
Primary Acquire pathology materials 3 years
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