Prophylactic Salpingectomy With Delayed Oophorectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01907789
First received: July 18, 2013
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prophylactic Salpingectomy With Delayed Oophorectomy, Risk-Reducing Salpingo-Oophorectomy, and Ovarian Cancer Screening Among BRCA Mutation Carriers: A Proof-of-Concept Study

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Compliance with Prophylactic Salpingectomy with Delayed Oophorectomy Strategy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Blood (about 2 tablespoons) drawn to measure CA125 and HE4 levels.


Estimated Enrollment: 40
Study Start Date: August 2013
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

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.
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.

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.
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 47 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Woman who have a mutation (genetic change) in one of the BRCA genes and are at high risk for developing ovarian cancer.

Criteria

Inclusion Criteria:

  1. Premenopausal women with a documented BRCA1 or BRCA2 mutation. Menopause is defined as >/= 12 months of amenorrhea.
  2. Women must be at least 30 and less than 48 years of age.
  3. Candidate for surgery and willing to undergo two surgical procedures (if chooses the PSDO arm).
  4. Patient choosing PSDO or RRSO must desire permanent sterilization.
  5. Presence of at least one fallopian tube. Prior tubal ligation is allowed.
  6. 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.
  7. Willingness to return to the enrolling site for any surgical procedures including pre-operative and post-operative care.
  8. Willingness to return to the enrolling site for ovarian cancer screening during the study period.

Exclusion Criteria:

  1. Postmenopausal women or women < 30 or >/= 48 years of age.
  2. Women without a documented BRCA mutation.
  3. Women with a history of ovarian, fallopian tube, or primary peritoneal cancer.
  4. 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.
  5. Medical comorbidities making surgery unsafe as determined by the patient's surgeon.
  6. Prior bilateral salpingectomy. Prior unilateral salpingectomy is allowed.
  7. Women who are pregnant.
  8. Women desiring future fertility except in the screening arm of the trial.
  9. 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.
  10. Inability to provide informed consent.
  11. Inability to read or speak English.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907789

Contacts
Contact: Denise Nebgen, MD, PHD 713-792-8507

Locations
United States, Illinois
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Denise Nebgen, MD, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01907789     History of Changes
Other Study ID Numbers: 2013-0340
Study First Received: July 18, 2013
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Ovarian Carcinoma
High risk for developing ovarian cancer
Ovarian cancer screening
Ovary
BRCA Mutation Carriers
BRCA1 or BRCA2 mutation
Risk-reducing salpingo-oophorectomy
RRSO
Prophylactic salpingectomy with delayed oophorectomy
PSDO
Questionnaire
Quality of life
QOL
Survey
Transvaginal ultrasound
Phone call

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Carcinoma
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 18, 2014