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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00778 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2015-0814 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (ISDO) | Experimental | Patients undergo ISDO. |
|
| Arm II (RRSO) | Active Comparator | Patients undergo RRSO. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
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:
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).
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.
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| Name | Affiliation | Role |
|---|---|---|
| Roni N Wilke, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42412428 | Derived | 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. |
| Label | URL |
|---|---|
| WISP University of Texas M D Anderson Cancer Center | View source |
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| Oophorectomy |
| Procedure |
Undergo ISDO |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Salpingectomy | Procedure | Undergo ISDO |
|
|
| Salpingo-Oophorectomy | Procedure | Undergo RRSO |
|
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Siteman Cancer Center at Washington University | St Louis | Missouri | 63110 | United States |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| ID | Term |
|---|---|
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D010052 | Ovariectomy |
| D058994 | Salpingectomy |
| D000074868 | Salpingo-oophorectomy |
| ID | Term |
|---|---|
| D002369 | Castration |
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013519 | Urogenital Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
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