Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

March 28, 2024 updated by: M.D. Anderson Cancer Center

WISP (Women Choosing Surgical Prevention)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. 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:

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

II. To estimate quality of life with ISDO compared to RRSO. III. To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures.

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

V. To determine the compliance with ISDO compared to RRSO. VI. To estimate the number of fallopian tube, ovarian, or primary peritoneal malignancies and other malignancies over the course of the study.

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.

Study Type

Interventional

Enrollment (Actual)

374

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Washington University
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania/Abramson Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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, or PMS2, or EPCAM; (please note: menopause is defined as >= 12 months of amenorrhea; however, for those patients with >= 12 months of amenorrhea who may be pre-menopausal, levels of follicle-stimulating hormone [FSH], luteinizing hormone [LH], and estradiol in the pre-menopausal range will be acceptable)
  • Willing to undergo two surgical procedures (if participant chooses the ISDO arm)
  • Presence of at least 1 fallopian tube and 1 ovary; (please note: 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: a) be without evidence of disease at enrollment b) remain premenopausal c) 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

Exclusion Criteria:

  • 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 human chorionic gonadotropin (HCG), or best judgement 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (ISDO)
Patients undergo ISDO.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Oophorectomy
Undergo ISDO
Other Names:
  • Female Castration
  • Ovariectomy
Procedure: Salpingectomy
Undergo ISDO
Other Names:
  • Tubal Excision
Active Comparator: Arm II (RRSO)
Patients undergo RRSO.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Salpingo-Oophorectomy
Undergo RRSO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of women with clinically meaningful change in the Female Sexual Function Index (FSFI) score
Time Frame: From baseline to 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Karen H Lu, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2016

Primary Completion (Estimated)

May 31, 2041

Study Completion (Estimated)

May 31, 2041

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimated)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0814 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2016-00778 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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