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NCT04009148 · ClinicalTrials.gov registry record

Cascade Testing in Families With Newly Diagnosed Hereditary Breast and Ovarian Cancer Syndrome

A clinical trial of BRIP1 Gene Mutation and MLH1 Gene Mutation, sponsored by NYU Langone Health.

Active
Registry status
118
Enrollment target
1
Study location

NCT04009148: Active study of BRIP1 Gene Mutation and MLH1 Gene Mutation, sponsored by NYU Langone Health.

NCT04009148 is a study of BRIP1 Gene Mutation and MLH1 Gene Mutation that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 118 participants, below the 1,042-participant average among 3 other BRIP1 Gene Mutation trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04009148, a study of BRIP1 Gene Mutation and MLH1 Gene Mutation, is active but no longer recruiting, sponsored by NYU Langone Health.

ACTIVE NOT RECRUITING
Registry status
118 participants
Enrollment target
1
Study location

Study Summary

Identification of BRCA mutations in ovarian cancer patients may help guide cancer therapies, prognosis, post-operative screening, and other preventative treatments beyond the initial diagnosis. Likewise, genetic testing of ovarian cancer patients for these germline mutations provides invaluable information for families regarding cancer risk, genetic testing, and subsequently indication for risk-reducing surgery. Cascade testing provides a unique opportunity to identify carriers of a deleterious BRCA mutation which can allow for surgical and chemoprevention of prevention of ovarian cancer. There is currently no literature on the rates of referral for the family members.

Primary Outcome

Number of relatives with successful cascade testing

Interventions

  • OTHER CASCADE genetic screening

Study Locations (1)

New York

  • NYU Langone Health - New York

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2019-03-01
Est. Completion 2027-04-23
NYU Langone Health

1,164 total trials

What the registry record for NCT04009148 still lists

NCT04009148 is an observational study that tracks outcomes without assigning an intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 1,042-participant average among 3 other BRIP1 Gene Mutation trials with a reported enrollment target (89% lower).

The record links to 8 conditions, with BRIP1 Gene Mutation appearing as the primary indexed condition, and to 1 intervention - of which CASCADE genetic screening is the first listed.

NCT04009148 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT04009148 about?

NCT04009148 is a clinical study titled "Cascade Testing in Families With Newly Diagnosed Hereditary Breast and Ovarian Cancer Syndrome". Identification of BRCA mutations in ovarian cancer patients may help guide cancer therapies, prognosis, post-operative screening, and other preventative treatments beyond the initial diagnosis. Likewise, genetic testing of ovarian cancer patients for these germline mutations provides invaluable info...

What is the current status of trial NCT04009148?

This trial is currently active not recruiting. The enrollment target is 118 participants. The study started on 2019-03-01. Estimated completion is 2027-04-23.

What conditions does trial NCT04009148 study?

This clinical trial studies the following conditions: BRIP1 Gene Mutation, MLH1 Gene Mutation, RAD51C Gene Mutation, BRCA-Mutated Ovarian Carcinoma, MSH2 A636P.

What interventions are being tested in trial NCT04009148?

The interventions under investigation include: CASCADE genetic screening (OTHER).

Who is sponsoring clinical trial NCT04009148?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04009148 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04009148, the US trial registry maintained by the National Library of Medicine. NCT04009148 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.