Ovarian Cancer Clinical Trial

Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention – US Cohort Study

Summary

This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence

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Full Description

The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk.

PRIMARY OBJECTIVE:

To evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers.

SECONDARY OBJECTIVE:

Incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy.

EXPLORATORY OBJECTIVE:

Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers

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Eligibility Criteria

Inclusion Criteria:

Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C and/or RAD51D gene germline mutation.
Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D
Childbearing completed or no longer requires fallopian tubes
Presence of at least one fallopian tube
Participants may have a personal history of non-ovarian malignancy.
Informed consent must be obtained and documented.

Exclusion Criteria:

Postmenopausal status (natural menopause or due to (cancer) treatment)
Wish for second stage RRO within two years after RRS (if clear at enrollment)
Legally incapable
Prior bilateral salpingectomy
A personal history of ovarian, fallopian tube or peritoneal cancer
Current clinicals signs, diagnosis or treatment for malignant disease

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

100

Study ID:

NCT05287451

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There are 4 Locations for this study

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Harvard Cancer Center
Boston Massachusetts, 02215, United States More Info
Colleen Feltmate, MD
Contact
617-732-8843
[email protected]
Colleen Feltmate, MD
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63130, United States More Info
Andrea Hagemann, MD
Contact
314-362-3181
[email protected]
Andrea Hagemann, MD
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Karen Lu, MD
Contact
713-745-8902
[email protected]
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Seattle Washington, 98195, United States More Info
Barbara Norquist, MD
Contact
206-598-8300
[email protected]
Barbara Norquist, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

100

Study ID:

NCT05287451

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

How clear is this clinincal trial information?

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