Study Summary
This trial compares two surgical procedures for reducing the risk of ovarian cancer in women with BRCA1 mutations.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Up to 20 years
Up to 20 years
Incidence of adverse events
Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers
Month 24
Cancer distress
Cost effectiveness
Estrogen deprivation symptoms
Health related (HR)-QOL
Health-related quality of life (QOL)
Medical decision making
Menopausal symptoms
Risk-reducing medical decision making validation and assessment
Sexual dysfunction
Month 24
Section dysfunction
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Group II (bilateral salpingo-oophorectomy)
1 of 2
Group I (bilateral salpingectomy)
1 of 2
Active Control
Experimental Treatment
2262 Total Participants · 2 Treatment Groups
Primary Treatment: Bilateral Salpingectomy · No Placebo Group · N/A
Group I (bilateral salpingectomy)Experimental Group · 3 Interventions: Bilateral Salpingectomy, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Procedure, Other, Other
Group II (bilateral salpingo-oophorectomy)ActiveComparator Group · 3 Interventions: Questionnaire Administration, Quality-of-Life Assessment, Bilateral Salpingectomy with Oophorectomy · Intervention Types: Other, Other, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bilateral Salpingectomy
2017
N/A
~40
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 20 years
Who is running the clinical trial?
NRG OncologyLead Sponsor
219 Previous Clinical Trials
93,262 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,084 Previous Clinical Trials
41,139,384 Total Patients Enrolled
282 Trials studying Ovarian Cancer
73,112 Patients Enrolled for Ovarian Cancer
Douglas A LevinePrincipal InvestigatorNRG Oncology
Joan WalkerPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
2,656 Total Patients Enrolled
Eligibility Criteria
Age 35 - 50 · Female Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must provide informed consent prior to study entry.
Who else is applying?
What state do they live in?
| Alberta | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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Conditions
Cancer Related
Treatments