Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
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 Other: Laboratory Biomarker Analysis Procedure: Oophorectomy Other: Quality-of-Life Assessment Procedure: Salpingectomy Procedure: Salpingo-Oophorectomy Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: WISP (Women Choosing Surgical Prevention)
Actual Study Start Date : May 2, 2016
Estimated Primary Completion Date : May 31, 2041
Estimated Study Completion Date : May 31, 2042


Arm Intervention/treatment
Experimental: Arm I (ISDO)
Patients undergo ISDO.
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

Active Comparator: Arm II (RRSO)
Patients undergo RRSO.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Procedure: Salpingo-Oophorectomy
Undergo RRSO




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02760849


Contacts
Layout table for location contacts
Contact: Karen Lu, MD (713) 745-8902 khlu@mdanderson.org

Locations
Layout table for location information
United States, Illinois
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Iris L. Romero    773-703-3972    iromero@babies.bsd.uchicago.edu   
Principal Investigator: Iris L. Romero         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Neil S. Horowitz    617-632-3743    nhorowitz@mgh.harvard.edu   
Principal Investigator: Neil S. Horowitz         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jamie N. Bakkum-Gamez    507-293-1487    bakkum.jamie@mayo.edu   
Principal Investigator: Jamie N. Bakkum-Gamez         
United States, Missouri
Siteman Cancer Center at Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Andrea R. Hagemann       hagemanna@wustl.edu   
Principal Investigator: Andrea R. Hagemann         
United States, New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Douglas A. Levine    646-501-4834    Douglas.levine@nyumc.org   
Principal Investigator: Douglas A. Levine         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Kara C. Long Roche    212-639-7043    longrock@mskcc.org   
Principal Investigator: Kara C. Long Roche         
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sarah H. Kim    215-662-3318    skim@obgyn.upenn.edu   
Principal Investigator: Sarah H. Kim         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Karen H. Lu    832-750-1796    WISP@mdanderson.org   
Principal Investigator: Karen H. Lu         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Elizabeth M. Swisher    206-685-7927    swishere@uw.edu   
Principal Investigator: Elizabeth M. Swisher         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Karen H Lu M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02760849     History of Changes
Other Study ID Numbers: 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 )
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hereditary Breast and Ovarian Cancer Syndrome
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Breast Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Breast Diseases
Skin Diseases