Prophylactic Salpingectomy With Delayed Oophorectomy
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| ClinicalTrials.gov Identifier: NCT01907789 |
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Recruitment Status :
Active, not recruiting
First Posted : July 25, 2013
Last Update Posted : November 13, 2019
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The goal of this clinical research study is to compare ovarian cancer screening, risk-reducing salpingo-oophorectomy (RRSO), and prophylactic salpingectomy with delayed oophorectomy (PSDO). The safety of RRSO and PSDO will also be studied.
Ovarian cancer screening does not involve a surgical procedure. Instead, physical exams, blood tests, and ultrasound are used to check for ovarian, fallopian tube, and peritoneal cancer.
The surgical procedures, RRSO and PSDO, are designed to lower your risk of ovarian cancer.
In RRSO, the fallopian tubes and ovaries are removed at the same time.
In PSDO, the fallopian tubes are removed and the ovaries remain in place so that the patient does not go through menopause. The ovaries are removed at a later date. The main goal of this study is to learn how many patients actually have their ovaries removed at a later date. Researchers also want to learn whether the removal of fallopian tubes will decrease the risk of ovarian cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Carcinoma | Other: Ovarian Cancer Screening Procedure: Prophylactic Salpingectomy with Delayed Oophorectomy Procedure: Risk-Reducing Salpingo-Oophorectomy Behavioral: Questionnaire Procedure: Transvaginal Ultrasound Behavioral: Phone Call | Not Applicable |
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| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Prophylactic Salpingectomy With Delayed Oophorectomy, Risk-Reducing Salpingo-Oophorectomy, and Ovarian Cancer Screening Among BRCA Mutation Carriers: A Proof-of-Concept Study |
| Actual Study Start Date : | August 2013 |
| Estimated Primary Completion Date : | August 2021 |
| Estimated Study Completion Date : | August 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ovarian Cancer Screening
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer will return to clinic every six months to undergo screening for ovarian cancer symptoms, physical examination, CA125, HE4, and transvaginal ultrasound.
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Other: Ovarian Cancer Screening
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer will return to clinic every six months to undergo screening for ovarian cancer symptoms, physical examination, CA125, HE4, and transvaginal ultrasound. Behavioral: Questionnaire Ovarian Screening Group: Quality of life (QOL) questionnaire completed at baseline, end of year 1, 2, and 3. Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO): Quality of life (QOL) questionnaire completed at baseline, 1 month 1 year, 2 years, and 3 years after salpingectomy. Also before oophorectomy performed, 1 month and 6 months after oophorectomy. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Quality of life (QOL) questionnaire completed at baseline, then 1 month, 6 months, and 1 year after surgery. Other Name: Survey Procedure: Transvaginal Ultrasound Ovarian Cancer Screening Group: Transvaginal ultrasound performed at baseline and every 6 months for 3 years. Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) group: Transvaginal ultrasound performed at baseline, every 6 months for 3 years after salpingectomy, then before oophorectomy. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Transvaginal ultrasound performed at baseline. Behavioral: Phone Call Ovarian Cancer Screening Group and Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) Group: Phone call made to patient one time a year after third year follow up. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Phone call made to patient 1 day after surgery, 1 week after surgery, then yearly. |
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Experimental: Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO)
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have salpingectomy performed as an outpatient procedure. After the 3-year follow up period, oophorectomy performed as an outpatient procedure.
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Procedure: Prophylactic Salpingectomy with Delayed Oophorectomy
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have salpingectomy performed as an outpatient procedure. After the 3-year follow up period, oophorectomy performed as an outpatient procedure. Behavioral: Questionnaire Ovarian Screening Group: Quality of life (QOL) questionnaire completed at baseline, end of year 1, 2, and 3. Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO): Quality of life (QOL) questionnaire completed at baseline, 1 month 1 year, 2 years, and 3 years after salpingectomy. Also before oophorectomy performed, 1 month and 6 months after oophorectomy. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Quality of life (QOL) questionnaire completed at baseline, then 1 month, 6 months, and 1 year after surgery. Other Name: Survey Procedure: Transvaginal Ultrasound Ovarian Cancer Screening Group: Transvaginal ultrasound performed at baseline and every 6 months for 3 years. Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) group: Transvaginal ultrasound performed at baseline, every 6 months for 3 years after salpingectomy, then before oophorectomy. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Transvaginal ultrasound performed at baseline. Behavioral: Phone Call Ovarian Cancer Screening Group and Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) Group: Phone call made to patient one time a year after third year follow up. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Phone call made to patient 1 day after surgery, 1 week after surgery, then yearly. |
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Experimental: Risk-Reducing Salpingo-Oophorectomy (RRSO)
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have risk-reducing salpingo-oophorectomy (RRSO) performed as an outpatient procedure.
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Procedure: Risk-Reducing Salpingo-Oophorectomy
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have risk-reducing salpingo-oophorectomy (RRSO) performed as an outpatient procedure. Behavioral: Questionnaire Ovarian Screening Group: Quality of life (QOL) questionnaire completed at baseline, end of year 1, 2, and 3. Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO): Quality of life (QOL) questionnaire completed at baseline, 1 month 1 year, 2 years, and 3 years after salpingectomy. Also before oophorectomy performed, 1 month and 6 months after oophorectomy. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Quality of life (QOL) questionnaire completed at baseline, then 1 month, 6 months, and 1 year after surgery. Other Name: Survey Procedure: Transvaginal Ultrasound Ovarian Cancer Screening Group: Transvaginal ultrasound performed at baseline and every 6 months for 3 years. Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) group: Transvaginal ultrasound performed at baseline, every 6 months for 3 years after salpingectomy, then before oophorectomy. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Transvaginal ultrasound performed at baseline. Behavioral: Phone Call Ovarian Cancer Screening Group and Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) Group: Phone call made to patient one time a year after third year follow up. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Phone call made to patient 1 day after surgery, 1 week after surgery, then yearly. |
- Patient Compliance with Prophylactic Salpingectomy with Delayed Oophorectomy Strategy [ Time Frame: Up to 5 years ]The proportion of women who comply with the prophylactic salpingectomy with delayed oophorectomy strategy estimated with an exact 95% binomial confidence interval. If all 20 patients return for their scheduled oophorectomy the 95% confidence interval for the proportion of women who are compliant will be 0.846 to 1.00.
- Number of occult malignancies [ Time Frame: Up to 5 years ]Will be tabulated by study arm. The risk difference will be estimated for occult malignancies with 95% confidence intervals, where the risk is defined as the number of events divided by the total time at risk.
- Number of complications [ Time Frame: Up to 5 years ]Will be tabulated by study arm. The risk difference will be estimated for complications with 95% confidence intervals, where the risk is defined as the number of events divided by the total time at risk.
- Type of complications [ Time Frame: Up to 5 years ]Will be tabulated by study arm. The risk difference will be estimated for complications with 95% confidence intervals, where the risk is defined as the number of events divided by the total time at risk.
- Change in quality of life measure [ Time Frame: Baseline to up to 3 years ]Descriptive statistics and box plots will be used to summarize the quality of life measures at each assessment time for each study arm.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Years to 47 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Premenopausal women with a documented BRCA1 or BRCA2 mutation. Menopause is defined as >/= 12 months of amenorrhea.
- Women must be at least 30 and less than 48 years of age.
- Candidate for surgery and willing to undergo two surgical procedures (if chooses the PSDO arm).
- Patient choosing PSDO or RRSO must desire permanent sterilization.
- Presence of at least one fallopian tube. Prior tubal ligation is allowed.
- Participants may have a personal history of non-ovarian malignancy, but must be without evidence of disease at enrollment and the patient must have completed treatment (including surgery, chemotherapy, or radiotherapy) > 3 months prior to enrollment (other than non-melanoma skin cancer). Current or past SERM or aromatase inhibitor use is allowed.
- Willingness to return to the enrolling site for any surgical procedures including pre-operative and post-operative care.
- Willingness to return to the enrolling site for ovarian cancer screening during the study period.
Exclusion Criteria:
- Postmenopausal women or women < 30 or >/= 48 years of age.
- Women without a documented BRCA mutation.
- Women with a history of ovarian, fallopian tube, or primary peritoneal cancer.
- Women currently undergoing cancer treatment or with a known active cancer. History of malignancy is allowed as long as the patient has completed treatment > 3 months prior to enrollment.
- Medical comorbidities making surgery unsafe as determined by the patient's surgeon.
- Prior bilateral salpingectomy. Prior unilateral salpingectomy is allowed.
- Women who are pregnant. Patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta HCG, or best judgement of the investigator. Pregnancy testing is not required per protocol to determine study eligibility.
- Women desiring future fertility except in the screening arm of the trial.
- Women whose most recent CA125 or transvaginal ultrasound is abnormal. A history of abnormal CA125 or ultrasound is allowed, as long as the most recent testing is normal.
- Inability to provide informed consent.
- Inability to read or speak English.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907789
| United States, Illinois | |
| NorthShore University Health System | |
| Evanston, Illinois, United States, 60201 | |
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Denise Nebgen, MD, PHD | M.D. Anderson Cancer Center |
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01907789 |
| Other Study ID Numbers: |
2013-0340 NCI-2015-00465 ( Registry Identifier: NCI CTRP ) |
| First Posted: | July 25, 2013 Key Record Dates |
| Last Update Posted: | November 13, 2019 |
| Last Verified: | May 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Ovarian Carcinoma Ovary BRCA Mutation Carriers BRCA1 or BRCA2 mutation High risk for developing ovarian cancer Ovarian cancer screening Risk-reducing salpingo-oophorectomy RRSO |
Prophylactic salpingectomy with delayed oophorectomy PSDO Questionnaire Quality of life QOL Survey Transvaginal ultrasound Phone call |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms |
Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |