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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04009148
Other study ID # 17-01135
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date October 30, 2026

Study information

Verified date January 2024
Source NYU Langone Health
Contact Ashley Brown
Phone 646 501 7629
Email Factsforfam@nyulangone.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The objective of this study is to perform a pilot study, offering referral to a genetic counseling and genetic testing for family members of a probands known to have a mutation in BRCA1 or BRCA2. In addition to BRCA1 and BRCA2, the NCCN suggests consideration of risk-reducing surgery for mutations in BRIP1, MSH2, MLH1, MSH6, PMS2, EPCAM, RAD51C, RAD51D, investigators will include these subjects as well in the study.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date October 30, 2026
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - All subjects must have a diagnosis of epithelial ovarian cancer, Fallopian tube caner or primary peritoneal cancer with a known pathogenic genetic mutation. - All subjects must agree to participate. - All subjects must have first or second degree relatives who have not been diagnosed with the same genetic mutation. - A previous diagnosis of cancer in the subject's first or second degree relative is allowed. Exclusion Criteria: - Subjects whose first and/or second degree relatives have already been tested with the subject's known mutations, and no other viable family members are available for testing.

Study Design


Intervention

Other:
CASCADE genetic screening
Family-based cohort of mutation carriers, blood relatives who test negative, and untested blood relatives

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Establishing the CASCADE Cohort Number of relatives with successful cascade testing 1 Year
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