Ignite Creation Date:
2025-12-18 @ 9:11 AM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT02760849
Status:
None
Last Update Posted:
2025-07-30 00:00:00
First Post:
2016-05-02 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations
Sponsor:
None
Organization:
Study Overview
Official Title:
WISP (Women Choosing Surgical Prevention)
Status:
None
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives:
1\. 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:
1. To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO.
2. To estimate quality of life with ISDO compared to RRSO.
3. To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures.
4. To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality.
5. To determine the compliance with delayed oophorectomy within the ISDO arm.
6. To estimate the number of fallopian tube, ovarian, primary peritoneal malignancies and other malignancies over the course of the study.
7. To identify common themes regarding influential factors in the decision to undergo risk reducing surgery in premenopausal women at genetic high-risk for ovarian can
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.
1\. 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:
1. To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO.
2. To estimate quality of life with ISDO compared to RRSO.
3. To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures.
4. To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality.
5. To determine the compliance with delayed oophorectomy within the ISDO arm.
6. To estimate the number of fallopian tube, ovarian, primary peritoneal malignancies and other malignancies over the course of the study.
7. To identify common themes regarding influential factors in the decision to undergo risk reducing surgery in premenopausal women at genetic high-risk for ovarian can
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: