Deleterious BARD1 Gene MutationNCT02760849
Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations
A study testing Laboratory Biomarker Analysis, Oophorectomy and Quality-of-Life Assessment in people with Deleterious BARD1 Gene Mutation and Deleterious BRCA1 Gene Mutation, run by M.D. Anderson Cancer Center at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Deleterious BARD1 Gene Mutation, Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation
- What is being tested?
- Laboratory Biomarker Analysis, Oophorectomy and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 9 sitesUnited States
- Study dates
- 2 May 2016to 31 May 2041
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
M D Anderson Cancer Center
Houston, Texas, 77030
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington Medical Center
Seattle, Washington, 98195
Siteman Cancer Center at Washington University
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the detailed description
Primary Objectives:
- 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:
- To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO.
- To estimate quality of life with ISDO compared to RRSO.
- To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures.
- To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality.
- To determine the compliance with delayed oophorectomy within the ISDO arm.
- To estimate the number of fallopian tube, ovarian, primary peritoneal malignancies and other malignancies over the course of the study.
- 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.
- Conditions
- Deleterious BARD1 Gene Mutation, Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Deleterious BRIP1 Gene Mutation, Deleterious EPCAM Gene Mutation, Deleterious MLH1 Gene Mutation
- Being tested
- Laboratory Biomarker Analysis, Oophorectomy, Quality-of-Life Assessment, Salpingectomy, Salpingo-Oophorectomy
- Medical subject headings
- Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
OophorectomyProcedure or surgery
Also called Female Castration, Ovariectomy
Undergo ISDO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
SalpingectomyProcedure or surgery
Also called Tubal Excision
Undergo ISDO
Salpingo-OophorectomyProcedure or surgery
Undergo RRSO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ISDO) | Experimental | Patients undergo ISDO. Receives: Other: Laboratory Biomarker Analysis; Procedure: Oophorectomy; Other: Quality-of-Life Assessment; Procedure: Salpingectomy |
| Arm II (RRSO) | Active comparator | Patients undergo RRSO. Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Procedure: Salpingo-Oophorectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start2 May 2016
- Primary completion31 May 2041 (estimated)
- Study completion31 May 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deleterious BARD1 Gene MutationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roni N Wilke, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760849
- Sponsor's protocol ID
- 2015-0814
- Other IDs
- NCI-2016-00778, 2015-0814
- Status last verified
- Jul 2026
- First submitted
- 2 May 2016
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lu KH, Norquist BM, Chisholm GB, Peterson CB, Long Roche KC, Bakkum-Gamez JN, Romero IL, Feltmate C, Levine DA, Kim S, Hagemann AR, Carter J, Hickey M, Crase J, Gavin K, Polinsky D, D'Andrea AD, Nebgen DR, Swisher EM. Patient-Centered Approach to Surgical Prevention of Ovarian Cancer: A Nonrandomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2622026. doi: 10.1001/jamanetworkopen.2026.22026.
PubMed 42412428
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WISP (Women Choosing Surgical Prevention)
- ClinicalTrials.gov ID
- NCT02760849
- Acronym / sponsor ID
- 2015-0814
- Conditions
- Deleterious BARD1 Gene Mutation, Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Deleterious BRIP1 Gene Mutation, Deleterious EPCAM Gene Mutation, Deleterious MLH1 Gene Mutation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 374 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 May 2016 (actual)
- Primary completion
- 31 May 2041 (estimated)
- Study completion
- 31 May 2041 (estimated)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO.
- To estimate quality of life with ISDO compared to RRSO.
- To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures.
- To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality.
- To determine the compliance with delayed oophorectomy within the ISDO arm.
- To estimate the number of fallopian tube, ovarian, primary peritoneal malignancies and other malignancies over the course of the study.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ISDO) | Experimental | Other: Laboratory Biomarker Analysis, Procedure: Oophorectomy, Other: Quality-of-Life Assessment, Procedure: SalpingectomyPatients undergo ISDO. |
| Arm II (RRSO) | Active comparator | Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Procedure: Salpingo-OophorectomyPatients undergo RRSO. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (ISDO), Arm II (RRSO) |
| OophorectomyAlso: Female Castration, OvariectomyUndergo ISDO | Procedure or surgery | Arm I (ISDO) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (ISDO), Arm II (RRSO) |
| SalpingectomyAlso: Tubal ExcisionUndergo ISDO | Procedure or surgery | Arm I (ISDO) |
| Salpingo-OophorectomyUndergo RRSO | Procedure or surgery | Arm II (RRSO) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Derived from this study: PubMed 42412428Lu KH, Norquist BM, Chisholm GB, Peterson CB, Long Roche KC, Bakkum-Gamez JN, Romero IL, Feltmate C, Levine DA, Kim S, Hagemann AR, Carter J, Hickey M, Crase J, Gavin K, Polinsky D, D'Andrea AD, Nebgen DR, Swisher EM. Patient-Centered Approach to Surgical Prevention of Ovarian Cancer: A Nonrandomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2622026. doi: 10.1001/jamanetworkopen.2026.22026.
- WISP University of Texas M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roni N Wilke, MD principal investigator
M.D. Anderson Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Biomarker Analysis, Oophorectomy and Quality-of-Life Assessment in people with Deleterious BARD1 Gene Mutation and Deleterious BRCA1 Gene Mutation, run by M.D. Anderson Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of women with clinically meaningful change in the Female Sexual Function Index (FSFI) score (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02760849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.