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Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

Primary Purpose

Deleterious BARD1 Gene Mutation, Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Oophorectomy
Quality-of-Life Assessment
Salpingectomy
Salpingo-Oophorectomy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deleterious BARD1 Gene Mutation

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Comprehensive Cancer Center
  • Dana-Farber Cancer Institute
  • Mayo Clinic
  • Siteman Cancer Center at Washington University
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • Memorial Sloan Kettering Cancer Center
  • University of Pennsylvania/Abramson Cancer Center
  • M D Anderson Cancer Center
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (ISDO)

Arm II (RRSO)

Arm Description

Patients undergo ISDO.

Patients undergo RRSO.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2016
Last Updated
September 18, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02760849
Brief Title
Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations
Official Title
WISP (Women Choosing Surgical Prevention)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2, 2016 (Actual)
Primary Completion Date
May 31, 2041 (Anticipated)
Study Completion Date
May 31, 2041 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Premenopausal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
374 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (ISDO)
Arm Type
Experimental
Arm Description
Patients undergo ISDO.
Arm Title
Arm II (RRSO)
Arm Type
Active Comparator
Arm Description
Patients undergo RRSO.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Oophorectomy
Other Intervention Name(s)
Female Castration, Ovariectomy
Intervention Description
Undergo ISDO
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Salpingectomy
Other Intervention Name(s)
Tubal Excision
Intervention Description
Undergo ISDO
Intervention Type
Procedure
Intervention Name(s)
Salpingo-Oophorectomy
Intervention Description
Undergo RRSO
Primary Outcome Measure Information:
Title
Percent of women with clinically meaningful change in the Female Sexual Function Index (FSFI) score
Description
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.
Time Frame
From baseline to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen H Lu
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center at Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

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