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NCT05420064 · ClinicalTrials.gov registry record · NA

An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk and An Intervention to Help Patients and Their Primary Care Providers Stay Up-to-date About Uncertain Genetic Test Results

A NA study of BRCA1 Mutation and BRCA2 Mutation, sponsored by Memorial Sloan Kettering Cancer Center.

Recruiting
Registry status
NA
Development phase
1,000
Enrollment target
8
Study locations

NCT05420064: Recruiting NA study of BRCA1 Mutation and BRCA2 Mutation, sponsored by Memorial Sloan Kettering Cancer Center.

NCT05420064 is a NA study of BRCA1 Mutation and BRCA2 Mutation that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 1,000 participants, above the 510-participant average among 15 other BRCA1 Mutation trials with a reported enrollment target (96% higher). The trial reports 8 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05420064, a NA study of BRCA1 Mutation and BRCA2 Mutation, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.

RECRUITING
Registry status
NA
Development phase
1,000 participants
Enrollment target
8
Study locations

Study Summary

The purpose of this study is to examine the impact of new cancer genetic counseling models that aim to increase patient engagement with the genetics team. To do this, the study consists of two trials to evaluate two related interventions. The first trial is the EfFORT Trial, which evaluates a cascade genetic testing intervention. Cascade testing is the process of offering genetic testing to people who are at risk of having inherited a possibly harmful gene change that has been found in their family. The study will look at how often genetic testing occurs when healthcare providers have permission to reach out to family members to recommend genetic testing and to help those who are interested get tested. The study will look at whether this cascade testing intervention is practical and effective. The study would like to see how this approach of healthcare providers reaching out directly to family members compares with the usual approach of patients telling their family members about the recommendation to get genetic testing. The second trial is the STRIVE Trial, which evaluates an intervention designed to help patients who receive an uncertain result from genetic testing (also called a "variant of uncertain significance") stay connected with their genetics care team, and to help patients and their primary care providers stay up-to-date about the meaning of uncertain genetic test results. The study will look at whether an intervention that consists of a study online portal for patients with uncertain genetic test results and their primary care providers will help them to stay up-to-date on the meaning of uncertain genetic test results. The study would like to see how this intervention compares to the usual approach of encouraging patients to re-contact their genetics care team on their own about a year after getting genetic testing."

Primary Outcome

The Primary Objective for EfFORT Trial: Assess genetic testing uptake by first-, second-, and third-degree relatives in the provider-facilitated cascade testing intervention as compared to the proband-mediated cascade testing control.

Conditions Studied

BRCA1 Mutation BRCA2 Mutation ATM Gene Mutation MLH1 Gene Mutation POLD1 Gene Mutation POLE Gene Mutation CDKN2A Mutation APC Gene Mutation BARD1 Gene Mutation MSH2 Gene Mutation

Interventions

  • BEHAVIORAL Standard of Care
  • BEHAVIORAL Intervention Arm At-risk Relative/ARR Contacts
  • BEHAVIORAL MyGene Portal

Study Locations (8)

New York

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) - Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
  • Memorial Sloan Kettering Cancer Center - New York
  • MSK at Ralph Lauren (Limited Protocol Activities) - New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activity) - Uniondale

New Jersey

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activity) - Montvale

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2022-12-01
Est. Completion 2026-11-30
Phase NA
Memorial Sloan Kettering Cancer Center

1,884 total trials

What NCT05420064 shows while recruiting

NCT05420064 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 510-participant average among 15 other BRCA1 Mutation trials with a reported enrollment target (96% higher).

The record links to 10 conditions, with BRCA1 Mutation appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.

NCT05420064 lists 8 locations in 2 states (New York, New Jersey).

Frequently Asked Questions

What is clinical trial NCT05420064 about?

NCT05420064 is a clinical study titled "An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk and An Intervention to Help Patients and Their Primary Care Providers Stay Up-to-date About Uncertain Genetic Test Results". The purpose of this study is to examine the impact of new cancer genetic counseling models that aim to increase patient engagement with the genetics team. To do this, the study consists of two trials to evaluate two related interventions. The first trial is the EfFORT Trial, which evaluates a cascad...

What is the current status of trial NCT05420064?

This trial is currently recruiting. It is a NA study. The enrollment target is 1,000 participants. The study started on 2022-12-01. Estimated completion is 2026-11-30.

What conditions does trial NCT05420064 study?

This clinical trial studies the following conditions: BRCA1 Mutation, BRCA2 Mutation, ATM Gene Mutation, MLH1 Gene Mutation, POLD1 Gene Mutation.

What interventions are being tested in trial NCT05420064?

The interventions under investigation include: Standard of Care (BEHAVIORAL), Intervention Arm At-risk Relative/ARR Contacts (BEHAVIORAL), MyGene Portal (BEHAVIORAL).

Who is sponsoring clinical trial NCT05420064?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05420064 being conducted?

This trial has 8 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for BRCA1 Mutation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05420064's enrollment target sits among peer trials

1,000 2nd of 15 the highest of 15 other BRCA1 Mutation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other BRCA1 Mutation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05420064

Source: ClinicalTrials.gov NCT05420064, the US trial registry maintained by the National Library of Medicine. NCT05420064 (large enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.