Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

Hereditary Breast and Ovarian Cancer Syndrome Clinical Trial

Official title:

WISP (Women Choosing Surgical Prevention)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02760849
• Other study ID #: 2015-0814
• Secondary ID: NCI-2016-0077820
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2, 2016
• Est. completion date: May 31, 2041

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary Objectives:

1. To examine changes in female sexual function with the strategy of interval salpingectomy and delayed oophorectomy (ISDO) compared to the strategy of risk-reducing salpingo-oophorectomy (RRSO) for patients who carry genetic mutations that predispose them to ovarian cancer.

Secondary Objectives:

1. To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO.

2. To estimate quality of life with ISDO compared to RRSO.

3. To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures.

4. To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality.

5. To determine the compliance with delayed oophorectomy within the ISDO arm.

6. To estimate the number of fallopian tube, ovarian, primary peritoneal malignancies and other malignancies over the course of the study.

7. To identify common themes regarding influential factors in the decision to undergo risk reducing surgery in premenopausal women at genetic high-risk for ovarian can

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients undergo ISDO.

ARM II: Patients undergo RRSO.

After completion of study treatment, patients are followed up at 1 and 6 months, 1 year, and 2 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 374
• Est. completion date: May 31, 2041
• Est. primary completion date: May 31, 2041
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Women must be = 30 and = 50 years of age.

2. 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.

3. Willing to undergo two surgical procedures (if chooses the ISDO arm).

4. Presence of at least 1 fallopian tube and 1 ovary. Prior unilateral salpingectomy is allowed; prior bilateral salpingectomy is not allowed

5. Patients who have undergone a prior tubal ligation will be eligible.

6. Participants may have a personal history of non-ovarian malignancy, but must:

1. Be without evidence of disease at enrollment

2. Remain premenopausal

3. Have completed treatment (including surgery, chemotherapy, radiotherapy or hormonal therapy) > 3 months prior to enrollment (other than non-melanoma skin cancer)

7. 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.

8. Patients must understand that they will be permanently sterilized

Exclusion Criteria:

1. Women with a personal history of ovarian, fallopian tube, or primary peritoneal cancer.

2. Current treatment with Tamoxifen or Aromatase Inhibitors.

3. Medical comorbidities making surgery unsafe as determined by the patient's surgeon.

4. 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.

5. 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.

6. Inability to provide informed consent.

7. Inability to read or speak English.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Deleterious BARD1 Gene Mutation
• Deleterious BRCA1 Gene Mutation
• Deleterious BRCA2 Gene Mutation
• Deleterious BRIP1 Gene Mutation
• 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
• Ovarian Neoplasms
• Premenopausal

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Oophorectomy
Undergo ISDO

Other:
• Quality-of-Life Assessment
Ancillary studies

Procedure:
• Salpingectomy
Undergo ISDO
• Salpingo-Oophorectomy
Undergo RRSO

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois
United States	M D Anderson Cancer Center	Houston	Texas
United States	Laura and Isaac Perlmutter Cancer Center at NYU Langone	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Siteman Cancer Center at Washington University	Saint Louis	Missouri
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   WISP University of Texas M D Anderson Cancer Center