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Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

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ClinicalTrials.gov Identifier: NCT02760849
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 4, 2016
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE May 2, 2016
Estimated Primary Completion Date May 31, 2041   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • Change in Sexual Function [ Time Frame: Baseline to 6 months after interval salpingectomy ]
    Change in sexual function measured by Female Sexual Function Index (FSFI). A change of 4 points is considered to be clinically meaningful.
  • Change in Sexual Function [ Time Frame: Baseline to 6 months after bilateral salpingo-oophorectomy ]
    Change in sexual function measured by Female Sexual Function Index (FSFI). A change of 4 points is considered to be clinically meaningful.
Change History Complete list of historical versions of study NCT02760849 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations
Official Title  ICMJE WISP (Women Choosing Surgical Prevention)
Brief 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. 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:

I. 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:

I. To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO.

II. To estimate quality of life with ISDO compared to RRSO. III. To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures.

IV. To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality.

V. To determine the compliance with ISDO compared to RRSO. VI. To estimate the number of fallopian tube, ovarian, or primary peritoneal malignancies and other malignancies over the course of the study.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Deleterious BARD1 Gene Mutation
  • Deleterious BRCA1 Gene Mutation
  • Deleterious BRCA2 Gene Mutation
  • Deleterious BRIP1 Gene Mutation
  • Deleterious EPCAM Gene Mutation
  • Deleterious MLH1 Gene Mutation
  • Deleterious MSH2 Gene Mutation
  • Deleterious MSH6 Gene Mutation
  • Deleterious PALB2 Gene Mutation
  • Deleterious PMS2 Gene Mutation
  • Deleterious RAD51C Gene Mutation
  • Deleterious RAD51D Gene Mutation
  • Hereditary Breast and Ovarian Cancer Syndrome
  • Premenopausal
Intervention  ICMJE
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Procedure: Oophorectomy
    Undergo ISDO
    Other Names:
    • Female Castration
    • Ovariectomy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Procedure: Salpingectomy
    Undergo ISDO
    Other Name: Tubal Excision
  • Procedure: Salpingo-Oophorectomy
    Undergo RRSO
Study Arms  ICMJE
  • Experimental: Arm I (ISDO)
    Patients undergo ISDO.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Procedure: Oophorectomy
    • Other: Quality-of-Life Assessment
    • Procedure: Salpingectomy
  • Active Comparator: Arm II (RRSO)
    Patients undergo RRSO.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Other: Quality-of-Life Assessment
    • Procedure: Salpingo-Oophorectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2017)
300
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2016)
270
Estimated Study Completion Date  ICMJE May 31, 2042
Estimated Primary Completion Date May 31, 2041   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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, or PMS2, or EPCAM; (please note: menopause is defined as >= 12 months of amenorrhea; however, for those patients with >= 12 months of amenorrhea who may be pre-menopausal, levels of follicle-stimulating hormone [FSH], luteinizing hormone [LH], and estradiol in the pre-menopausal range will be acceptable)
  • Willing to undergo two surgical procedures (if participant chooses the ISDO arm)
  • Presence of at least 1 fallopian tube and 1 ovary; (please note: 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: a) be without evidence of disease at enrollment b) remain premenopausal c) 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

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); patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta human chorionic gonadotropin (HCG), or best judgement 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen Lu, MD (713) 745-8902 khlu@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02760849
Other Study ID Numbers  ICMJE 2015-0814
NCI-2016-00778 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-0814 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Karen H Lu M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP