NCT04251052

A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer

Recruiting now NA Last updated 27 March 2026

What this trial tests

NA trial testing Bilateral Salpingectomy in Ovarian Carcinoma in 1,956 participants. Currently enrolling.

Timeline

1 September 2020

Primary endpoint
30 June 2047

30 June 2047

Quick facts

Lead sponsor	NRG Oncology
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,956
Start date	1 September 2020
Primary completion	30 June 2047
Estimated completion	30 June 2047
Sites	549 locations across Canada, United States, South Korea

Drugs / interventions tested

• Bilateral Salpingectomy
• Bilateral Salpingectomy with Oophorectomy
• Biospecimen Collection — full drug profile →
• Magnetic Resonance Imaging
• Quality-of-Life Assessment
• Questionnaire Administration
• Transvaginal Ultrasound
• Ultrasound Imaging

Conditions studied

• Ovarian Carcinoma — all drugs for Ovarian Carcinoma →

Sponsor

NRG Oncology — full company profile →

Who can join

Adults 35 to 50, female only, with Ovarian Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Risk of Peritoneal Carcinomatosis After Risk-Reducing Salpingo-Oophorectomy: A Systematic Review and Individual Patient Data Meta-Analysis.
   Steenbeek MP, van Bommel MHD, Bulten J, Hulsmann JA, et al · · 2022 · cited 71× · PMID 35302882 · DOI 10.1200/jco.21.02016
2. Risk-Reducing Bilateral Salpingo-Oophorectomy for Ovarian Cancer: A Review and Clinical Guide for Hereditary Predisposition Genes.
   Liu YL, Breen K, Catchings A, Ranganathan M, et al · · 2022 · cited 60× · PMID 34582274 · DOI 10.1200/op.21.00382
3. Biology-driven therapy advances in high-grade serous ovarian cancer.
   Wang Y, Duval AJ, Adli M, Matei D. · · 2024 · cited 51× · PMID 38165032 · DOI 10.1172/jci174013
4. TUBectomy with delayed oophorectomy as an alternative to risk-reducing salpingo-oophorectomy in high-risk women to assess the safety of prevention: the TUBA-WISP II study protocol.
   Steenbeek MP, van Bommel MHD, intHout J, Peterson CB, et al · · 2023 · cited 40× · PMID 37045546 · DOI 10.1136/ijgc-2023-004377
5. Hereditary Ovarian Carcinoma: Cancer Pathogenesis Looking beyond <i>BRCA1</i> and <i>BRCA2</i>.
   Samuel D, Diaz-Barbe A, Pinto A, Schlumbrecht M, et al · · 2022 · cited 28× · PMID 35159349 · DOI 10.3390/cells11030539
6. Lineage specific extracellular vesicle-associated protein biomarkers for the early detection of high grade serous ovarian cancer.
   Trinidad CV, Pathak HB, Cheng S, Tzeng SC, et al · · 2023 · cited 20× · PMID 37884576 · DOI 10.1038/s41598-023-44050-5
7. Contraceptives and cancer risks in BRCA1/2 pathogenic variant carriers: a systematic review and meta-analysis.
   van Bommel MHD, IntHout J, Veldmate G, Kets CM, et al · · 2023 · cited 17× · PMID 36383189 · DOI 10.1093/humupd/dmac038
8. Salpingectomy for the Risk Reduction of Ovarian Cancer: Is It Time for a Salpingectomy-alone Approach?
   Boerner T, Long Roche K. · · 2021 · cited 16× · PMID 33038519 · DOI 10.1016/j.jmig.2020.09.020