NCT02665195

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
689

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2016Jan 2027

Study Start

First participant enrolled

January 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

11 years

First QC Date

January 20, 2016

Last Update Submit

February 5, 2026

Conditions

Genetic Testing

Outcome Measures

Primary Outcomes (2)

  • Acquire DNA samples

    3 years

  • Acquire pathology materials

    3 years

Study Arms (1)

Prospective Registry of Multiplex Testing

This is a prospective ascertainment study that will obtain medical information and biospecimens from two different types of families: 1) Families transmitting sequence variants in non-BRCA predisposition genes that are either functionally deleterious or likely to be functionally deleterious based upon the interpretation of the laboratory that performed the testing on the Index Participant (Initial PROMPT enrollee), and 2) Families transmitting variants of uncertain significance (usually rare missense variants) in non- BRCA predisposition genes. Attempts will be made to collect a biospecimen and a completed risk factor questionnaire from each participant.

Other: saliva specimenBehavioral: questionnaire

Interventions

saliva specimenOTHER
Prospective Registry of Multiplex Testing
questionnaireBEHAVIORAL
Prospective Registry of Multiplex Testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted as a multi-center study with the involvement of attendings, genetic counselors, and research study staff at the participating institutions.

You may qualify if:

  • 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

You may not qualify if:

  • Inability or refusal to participate in consent discussion
  • Subject is less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering @ Rockville

Rockville Centre, New York, 11570, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

saliva specimen

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Mark Robson, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 27, 2016

Study Start

January 1, 2016

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

US(10)