Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

NCT02760849 | Active Not Recruiting FDA Drug

• 2 other identifiers: 2015-0814NCI-2016-00778
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 9

Brief Summary

This phase II trial studies how well surgery works in preventing ovarian cancer in patients with genetic mutations at risk of ovarian cancer. Risk reducing salpingo oophorectomy (RRSO) is surgery to remove the fallopian tubes and ovaries at the same time. Interval salpingectomy with delayed oophorectomy (ISDO) is surgery to remove the fallopian tubes. It is not known whether ISDO works better than RRSO at lowering risk of ovarian cancer and improving the sexual function and psychosocial well-being in patients with genetic mutation.

Conditions

Deleterious EPCAM Gene Mutation; Deleterious MLH1 Gene Mutation; Deleterious MSH2 Gene Mutation; Deleterious MSH6 Gene Mutation; Deleterious PALB2 Gene Mutation; Deleterious PMS2 Gene Mutation; Deleterious RAD51C Gene Mutation; Deleterious RAD51D Gene Mutation; Hereditary Breast and Ovarian Cancer Syndrome; Premenopausal; Deleterious BARD1 Gene Mutation; Deleterious BRCA1 Gene Mutation; Deleterious BRCA2 Gene Mutation; Deleterious BRIP1 Gene Mutation

Outcome Measures

Primary Outcomes (1)

• Percent of women with clinically meaningful change in the Female Sexual Function Index (FSFI) score

  Will be calculated using the Cochran-Mantel-Haenszel test stratified by age, with 5-year age groups. We will use propensity score methods to account for potential differences between interval salpingectomy with delayed oophorectomy (ISDO) and risk-reducing bilateral salpingectomy with oophorectomy (RRSO) arms with respect to age, baseline survey scores, and other potential confounders, and we will use the propensity scores as inverse weights in logistic regression to model the logit of the probability of having a clinically meaningful change in FSFI score from baseline to 6 months as our primary analysis.

  From baseline to 6 months

Study Arms (2)

Arm I (ISDO)

EXPERIMENTAL

Patients undergo ISDO.

Other: Laboratory Biomarker Analysis; Procedure: Oophorectomy; Other: Quality-of-Life Assessment; Procedure: Salpingectomy

Arm II (RRSO)

ACTIVE COMPARATOR

Patients undergo RRSO.

Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Procedure: Salpingo-Oophorectomy

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (ISDO); Arm II (RRSO)

Oophorectomy PROCEDURE

Undergo ISDO

Also known as: Female Castration, Ovariectomy

Arm I (ISDO)

Salpingectomy PROCEDURE

Undergo ISDO

Also known as: Tubal Excision

Arm I (ISDO)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (ISDO); Arm II (RRSO)

Salpingo-Oophorectomy PROCEDURE

Undergo RRSO

Arm II (RRSO)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women must be ≥ 30 and ≤ 50 years of age.
• Premenopausal women with a documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM. Menopause is defined as ≥ 12 months of amenorrhea. However, for those patients with ≥ 12 months of amenorrhea who may be pre-menopausal, levels of FSH, LH, and estradiol in the pre-menopausal range will be acceptable.
• Willing to undergo two surgical procedures (if chooses the ISDO arm).
• Presence of at least 1 fallopian tube and 1 ovary. Prior unilateral salpingectomy is allowed; prior bilateral salpingectomy is not allowed
• Patients who have undergone a prior tubal ligation will be eligible.
• Participants may have a personal history of non-ovarian malignancy, but must:
• Be without evidence of disease at enrollment
• Remain premenopausal
• Have completed treatment (including surgery, chemotherapy, radiotherapy or hormonal therapy) \> 3 months prior to enrollment (other than non-melanoma skin cancer)
• Willingness to return to the enrolling site for the study surgical procedures, including pre-operative and post-operative care.
• Patients in the ISDO arm must be willing to return to the enrolling site for yearly ovarian cancer assessment.
• Patients must understand that they will be permanently sterilized

You may not qualify if:

• Women with a personal history of ovarian, fallopian tube, or primary peritoneal cancer.
• Current treatment with Tamoxifen or Aromatase Inhibitors.
• Medical comorbidities making surgery unsafe as determined by the patient's surgeon.
• Women who are pregnant or post-partum (within 3 months of delivery).
• Patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta HCG, or best judgment of the investigator. Pregnancy testing is not required per protocol to determine study eligibility.
• Women who become pregnant on the ISDO arm via reproductive technology can remain on study. However, data collection will be suspended during pregnancy and 3 months post-partum.
• Women with elevated levels of CA125 (\>50) or transvaginal ultrasound suggesting cancer, unless findings are consistent with endometriosis. CA125 and transvaginal ultrasounds must be the most recent, but no older than 1 year from the date of enrollment.
• Inability to provide informed consent.
• Inability to read or speak English.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Siteman Cancer Center at Washington University

St Louis, Missouri, 63110, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Links

• WISP University of Texas M D Anderson Cancer Center

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Interventions

Ovariectomy; Salpingectomy; Salpingo-oophorectomy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures

Study Officials

• Roni N Wilke, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 4, 2016
• Study Start: May 2, 2016
• Primary Completion (Estimated): May 31, 2041
• Study Completion (Estimated): May 31, 2041
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (9)