Hereditary Breast and Ovarian Cancer Syndrome Clinical Trial
Official title:
WISP (Women Choosing Surgical Prevention)
Verified date | June 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
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 |
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