Prospective Registry of Multiplex Testing (PROMPT)

Active, not recruiting

• Conditions: Genetic Testing

• Registration Number: NCT02665195
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 689

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acquire pathology materials	3 years
Acquire DNA samples	3 years

Trial Locations

Locations (10)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, 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 @ Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering @ Rockville; 🇺🇸 Rockville Centre, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States