We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
May 2, 2016
May 4, 2016
November 14, 2017
May 2016
May 2041   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Complete list of historical versions of study NCT02760849 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Women Choosing Surgical Prevention (WISP) Trial
WISP (Women Choosing Surgical Prevention)

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hereditary Breast and Ovarian Cancer Syndrome
  • 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: 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.

    Interventions:
    • Procedure: Salpingectomy
    • Procedure: Oophorectomy
    • Behavioral: Questionnaires
  • 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.

    Interventions:
    • Procedure: Salpingectomy
    • Procedure: Oophorectomy
    • Behavioral: Questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
May 2041
May 2041   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
30 Years to 50 Years   (Adult)
No
Contact: Karen H. Lu, MD 832-750-1796
United States
 
 
NCT02760849
2015-0814
SU2C-AACR-DT16-15 ( Other Grant/Funding Number: American Association for Cancer Research Foundation )
NCI-2016-00778 ( Registry Identifier: NCI-CTRP )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
  • American Association for Cancer Research
  • Dana-Farber Cancer Institute
Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
November 2017

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