Ignite Creation Date:
2024-05-06 @ 2:13 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04251052
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2020-01-14
Brief Title:
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Sponsor:
NRG Oncology
Organization:
NRG Oncology
Study Overview
Official Title:
A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers SOROCk
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This clinical trial evaluates how well two surgical procedures bilateral salpingectomy and bilateral salpingo-oophorectomy work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations Bilateral salpingectomy involves the surgical removal of fallopian tubes and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations
Detailed Description:
PRIMARY OBJECTIVE
I To compare the non-inferiority of bilateral salpingectomy BLS with delayed oophorectomy to bilateral salpingo-oophorectomy BSO to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations
SECONDARY OBJECTIVES
I To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom FACT-ES subscale compared to pre-menopausal patients in the BSO arm
II To determine if health-related quality of life QOL FACT is negatively impacted by menopausal symptoms menopausal symptom checklist-Menopausal Symptom Checklist MSCL and sexual dysfunction Female Sexual Function Index FSFI in pre-menopausal patients who have undergone BLS in comparison to normative data MSCLFACT-ES and data from pre-menopausal BSO patients
III To determine if health-related QOL FACT is negatively impacted by cancer distress Impact of Event Scale IES in individuals who have undergone BLS in comparison to BSO patients
IV To assess medical decision making as measured by the Shared Decision Making Questionnaire SDM-Q-9 and Decision Regret Scale DRS and determine factors associated with the risk of reducing surgical treatment choice
V To assess adverse events graded using Common Terminology Criteria for Adverse Events CTCAE version v50
EXPLORATORY OBJECTIVES
I Sexual dysfunction as measured by selected Patient-Reported Outcomes Measurement Information System PROMIS screener and external sexual function items pre-menopausal patients
II To estimate the cost-effectiveness of BLS compared to BSO for ovarian cancer risk reduction
III To assess medical decision making as measured by the Risk-Reducing Medical Decision Making RR-MDM survey a targeted set of questions on risk reducing surgical treatment choice
TRANSLATIONAL RESEARCH OBJECTIVE
I To bank tissue and blood biospecimens for future research
OUTLINE Patients choose between 1 of 2 groups
GROUP I Patients undergo bilateral salpingectomy Patients may then undergo oophorectomy after initial surgery
GROUP II Patients undergo bilateral salpingo-oophorectomy
Patients in both groups also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial
After completion of study patients are followed up at 10-60 days 6 12 and 24 months and then annually for up to 20 years
I To compare the non-inferiority of bilateral salpingectomy BLS with delayed oophorectomy to bilateral salpingo-oophorectomy BSO to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations
SECONDARY OBJECTIVES
I To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom FACT-ES subscale compared to pre-menopausal patients in the BSO arm
II To determine if health-related quality of life QOL FACT is negatively impacted by menopausal symptoms menopausal symptom checklist-Menopausal Symptom Checklist MSCL and sexual dysfunction Female Sexual Function Index FSFI in pre-menopausal patients who have undergone BLS in comparison to normative data MSCLFACT-ES and data from pre-menopausal BSO patients
III To determine if health-related QOL FACT is negatively impacted by cancer distress Impact of Event Scale IES in individuals who have undergone BLS in comparison to BSO patients
IV To assess medical decision making as measured by the Shared Decision Making Questionnaire SDM-Q-9 and Decision Regret Scale DRS and determine factors associated with the risk of reducing surgical treatment choice
V To assess adverse events graded using Common Terminology Criteria for Adverse Events CTCAE version v50
EXPLORATORY OBJECTIVES
I Sexual dysfunction as measured by selected Patient-Reported Outcomes Measurement Information System PROMIS screener and external sexual function items pre-menopausal patients
II To estimate the cost-effectiveness of BLS compared to BSO for ovarian cancer risk reduction
III To assess medical decision making as measured by the Risk-Reducing Medical Decision Making RR-MDM survey a targeted set of questions on risk reducing surgical treatment choice
TRANSLATIONAL RESEARCH OBJECTIVE
I To bank tissue and blood biospecimens for future research
OUTLINE Patients choose between 1 of 2 groups
GROUP I Patients undergo bilateral salpingectomy Patients may then undergo oophorectomy after initial surgery
GROUP II Patients undergo bilateral salpingo-oophorectomy
Patients in both groups also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial
After completion of study patients are followed up at 10-60 days 6 12 and 24 months and then annually for up to 20 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG1CA189867 | NIH | CTEP | httpsreporternihgovquickSearchUG1CA189867 |
| NCI-2019-07791 | REGISTRY | None | None |
| NRG-CC008 | OTHER | None | None |
| NRG-CC008 | OTHER | None | None |
| NRG-CC008 | OTHER | None | None |