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The Women Choosing Surgical Prevention (WISP) Trial

This study is currently recruiting participants.
Verified November 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02760849
First Posted: May 4, 2016
Last Update Posted: November 14, 2017
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.
Collaborators:
American Association for Cancer Research
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

The goal of this clinical research study is to compare the changes in female sexual function between patients having interval salpingectomy with delayed oophorectomy (ISDO) with those having risk-reducing salpingo-oophorectomy (RRSO) in women who carry genetic mutations. Researchers also want to learn how these surgeries affect your quality of life.

RRSO is the standard surgery for patients with certain types of genetic mutations, where the fallopian tubes and ovaries are removed at the same time.

ISDO is surgery to remove the fallopian tubes first, then the ovaries are removed during a second, later surgery. Most women with genetic mutations will be encouraged to remove the ovaries around the ages of 40 to 50. The decision in timing to remove your ovaries will be made with your doctor.


Condition Intervention Phase
Hereditary Breast and Ovarian Cancer Syndrome Procedure: Salpingectomy Procedure: Oophorectomy Behavioral: Questionnaires Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: WISP (Women Choosing Surgical Prevention)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Sexual Function in Interval Salpingectomy with Delayed Oophorectomy (ISDO) Participants [ 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 in Risk-Reducing Salpingo-Oophorectomy (RRSO) Participants [ 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.


Estimated Enrollment: 300
Actual Study Start Date: May 2016
Estimated Study Completion Date: May 2041
Estimated Primary Completion Date: May 2041 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interval Salpingectomy with Delayed Oophorectomy (ISDO)

Participants who choose Group 1 will have ISDO. During salpingectomy, the inside of the abdomen is looked at and both fallopian tubes removed.

Quality-of-life questionnaires completed at baseline, 6 months after salpingectomy, and every year or until delayed oophorectomy.

During oophorectomy, the inside of the abdomen is looked at and both ovaries removed.

Quality-of-life questionnaires completed before oophorectomy, and at 6 months, 1 year, and 2 years after oophorectomy.

Procedure: Salpingectomy
During salpingectomy, the inside of the abdomen is looked at and both fallopian tubes removed.
Procedure: Oophorectomy
During oophorectomy, the inside of the abdomen is looked at and both ovaries removed.
Behavioral: Questionnaires

ISDO Group: Quality-of-life questionnaires completed at baseline, 6 months after salpingectomy, and every year or until delayed oophorectomy.

Quality-of-life questionnaires completed before oophorectomy, and at 6 months, 1 year, and 2 years after oophorectomy.

RRSO Group: Quality-of-life questionnaire completed at baseline, 6 months, 1 year, and 2 years after salpingo-oophorectomy surgery.

Other Name: Surveys
Experimental: Risk-Reducing Salpingo-Oophorectomy (RRSO)

Participants who choose Group 2 will have RRSO. During salpingo-oophorectomy, the inside of the abdomen looked at and both ovaries and fallopian tubes removed.

Quality-of-life questionnaire completed at 6 months, 1 year, and 2 years after salpingo-oophorectomy surgery.

Procedure: Salpingectomy
During salpingectomy, the inside of the abdomen is looked at and both fallopian tubes removed.
Procedure: Oophorectomy
During oophorectomy, the inside of the abdomen is looked at and both ovaries removed.
Behavioral: Questionnaires

ISDO Group: Quality-of-life questionnaires completed at baseline, 6 months after salpingectomy, and every year or until delayed oophorectomy.

Quality-of-life questionnaires completed before oophorectomy, and at 6 months, 1 year, and 2 years after oophorectomy.

RRSO Group: Quality-of-life questionnaire completed at baseline, 6 months, 1 year, and 2 years after salpingo-oophorectomy surgery.

Other Name: Surveys

  Hide Detailed Description

Detailed Description:

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned a study arm based on the type of surgery you choose with your doctor. If you choose ISDO, you will be in Group 1. If you choose RRSO, you will be in Group 2.

Group 1:

Surgery #1: Interval Salpingectomy (IS):

If you are in Group 1, the study doctor will discuss the salpingectomy surgery with you in detail, including the risks and possible benefits. You will be asked to sign a surgical consent form.

Most patients have salpingectomy performed as an outpatient procedure. This means that you will likely go home the day of your surgery. If the study doctor plans to have you stay overnight in the hospital for any reason, it will be discussed with you.

During the surgery, the inside of your abdomen will be looked at and both of your fallopian tubes will be removed. If the study doctor finds anything during the surgery that may be cancerous, a tissue sample or a complete ovary will be removed during surgery and tested. If cancer is found, a gynecologic oncologist would perform your cancer surgery.

Post-Salpingectomy (IS) Follow-Up:

One (1) month (+/- 1 month) after surgery:

  • If the doctor thinks it is needed, you may have a physical exam, including an exam of your surgical incisions (wounds) and a review of any complications you may have had from surgery. If you do not live near the hospital, this may be done by a local doctor. If you are unable to visit a your study doctor, you will be contacted by phone.
  • The pathology (tissue) results from your surgery will be discussed with you by phone call or at the 1-month visit. If the results are benign (show no cancer), you will move to the ovarian cancer assessment period below. However, if the results show cancer, the study doctor will refer you to a gynecologic oncologist and you will move to the Follow-Up Phase.

Six (6) months (+/- 3 months) after surgery:

°You will complete the quality-of-life questionnaires.

Ovarian Cancer Assessment Period:

Every year (+/- 3 months) until delayed oophorectomy (DO) surgery:

You will have a physical exam, including a pelvic exam. You will have a transvaginal ultrasound to look at your ovaries. Blood (about 1 tablespoon) will be drawn for CA-125 testing. You will complete the quality-of-life questionnaires. You will review and sign the Completion Oophorectomy Recommendation Form at least every other year with your study doctor. This form will be provided to make sure you understand the current age recommendations to have surgery to remove your ovaries (DO).

The yearly test results will be discussed with you.

If results are benign (no cancer), you will continue with the above yearly tests until you and your doctor decide to have the Delayed Oophorectomy (DO) surgery. When you and your doctor have decided for you to have DO surgery, you will have pre-oophorectomy tests.

Pre-Oophorectomy (DO) Tests:

  • You will have a physical exam, including a pelvic exam.
  • If the doctor thinks it is needed, blood (about 1 tablespoon) may be drawn for CA-125 testing.
  • If the doctor thinks it is needed, you may have a transvaginal ultrasound to look at your ovaries.
  • You will complete the quality-of-life questionnaires
  • You will complete the medical questionnaires if you have not completed 1 in over 5 years.
  • If your doctor thinks it is needed, you may have other tests.

The study doctor will discuss the pre-surgery test results with you.

Surgery #2: Delayed Oophorectomy (DO):

If your pre-oophorectomy testing is normal, the study doctor will discuss the planned surgery with you in detail, including the risks and possible benefits. You will be asked to sign a surgical consent form.

Most patients have oophorectomy performed as an outpatient procedure. If the study doctor plans to have you stay overnight in the hospital for any reason, it will be discussed with you.

During the surgery, the inside of your abdomen will be looked at and both of your ovaries will be removed. If the study doctor finds anything during the surgery that may be cancerous, a tissue sample will be removed during surgery and tested. If cancer is found, a gynecologic oncologist would perform your cancer surgery.

Post-Oophorectomy (DO) Follow-Up:

One (1) month (+/- 1 month) after surgery:

  • If the doctor thinks it is needed, you may have a physical exam, including an exam of your surgical incisions (wounds) and a review of any complications you may have had from surgery. If you do not live near the hospital, this may be done by a local doctor. If you are unable to visit your study doctor, you will be contacted by phone.
  • The pathology results from your surgery will be discussed with you by phone call or at the 1-month visit. If the results are benign (show no cancer), you will move to the ovarian cancer assessment period below. However, if the results show cancer, the study doctor will refer you to a gynecologic oncologist and you will move to the Follow-Up Phase.

At 6 months (+/- 3 months), 1 year (+/- 3 months), and 2 years (+/- 3 months) after surgery, you will complete the quality-of-life questionnaires.

Group 2:

Surgery: RRSO:

If you are in Group 2, the study doctor will discuss the surgery with you in detail, including the risks and possible benefits. You will be asked to sign a surgical consent form.

Most patients have RRSO performed as an outpatient procedure. If the study doctor plans to have you stay overnight in the hospital for any reason, it will be discussed with you.

During the surgery, the inside of your abdomen will be looked at and both of your ovaries and fallopian tubes will be removed. If the study doctor finds anything during the surgery that may be cancerous, a tissue sample will be removed during surgery and tested. If cancer is found, a gynecologic oncologist would perform your cancer surgery.

Post-Surgery (RRSO) Follow-Up:

One (1) month (+/- 1 month) after surgery:

  • If the doctor thinks it is needed, you may have a physical exam, including an exam of your surgical incisions (wounds) and a review of any complications you may have had from surgery. If you do not live near the hospital, this may be done by a local doctor. If you are unable to visit your study doctor, you will be contacted by phone.
  • The pathology results from your surgery will be discussed with you by phone call or at the 1-month visit. If the results are benign (show no cancer), you will move to the ovarian cancer assessment period below. However, if the results show cancer, the study doctor will refer you to a gynecologic oncologist and you will move to the Follow-Up Phase and complete a yearly questionnaire.

At 6 months (+/- 3 months), 1 year (+/- 3 months), and 2 years (+/- 3 months) after surgery, you will complete the quality-of-life questionnaires.

Length of Study:

Your last study visit will be about 1 month after your ovaries are removed. You will continue to complete questionnaires for as long as possible. You will be taken off study early if you no longer want to participate or cancer is found before the IS or RRSO surgeries.

Follow-Up Phase:

You will be moved to the Follow-Up Phase if cancer is found after IS or RRSO surgery, or if you have completed all the necessary quality-of-life questionnaires. You will complete a yearly follow-up questionnaire for as long as possible.

This is an investigational study. At this time, the only surgery known to lower your risk of ovarian cancer is RRSO. ISDO has not been previously studied and may not lower your ovarian cancer risk. Your decision for any of these surgeries will be made with your doctor. You will sign a separate consent form that will describe each of these surgeries and their risks in more detail. ISDO is currently being used for research purposes at MD Anderson.

Up to 300 women will be enrolled in this multicenter study. Up to 45 may take part at MD Anderson.

  Eligibility

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.


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

Inclusion Criteria:

  1. Women must be >/= 30 and </= 50 years of age.
  2. 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. (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 FSH, LH, and estradiol in the pre-menopausal range will be acceptable).
  3. Willing to undergo two surgical procedures (if participant chooses the ISDO arm)
  4. Presence of at least 1 fallopian tube and 1 ovary. (Please note: Prior unilateral salpingectomy is allowed; prior bilateral salpingectomy is not allowed)
  5. Patients who have undergone a prior tubal ligation will be eligible.
  6. 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)
  7. 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)
  8. Patients must understand that they will be permanently sterilized

Exclusion Criteria:

  1. Women with a personal history of ovarian, fallopian tube, or primary peritoneal cancer
  2. Current treatment with Tamoxifen or Aromatase Inhibitors
  3. Medical comorbidities making surgery unsafe as determined by the patient's surgeon
  4. 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 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
  5. 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.
  6. Inability to provide informed consent.
  7. Inability to read or speak English.
  Contacts and Locations
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
Contact: Karen H. Lu, MD 832-750-1796

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 317556
Sponsors and Collaborators
M.D. Anderson Cancer Center
American Association for Cancer Research
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02760849     History of Changes
Other Study ID Numbers: 2015-0814
SU2C-AACR-DT16-15 ( Other Grant/Funding Number: American Association for Cancer Research Foundation )
NCI-2016-00778 ( Registry Identifier: NCI-CTRP )
First Submitted: May 2, 2016
First Posted: May 4, 2016
Last Update Posted: November 14, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Hereditary Breast and Ovarian Cancer Syndrome
HBOC
Deleterious mutation in ovarian cancer genes
Changes in female sexual function
Salpingectomy with delayed oophorectomy
ISDO
Risk-reducing salpingo-oophorectomy (RRSO)
RRSO
Questionnaires
Surveys

Additional relevant MeSH terms:
Ovarian Neoplasms
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
Breast Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Breast Diseases
Skin Diseases