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A study to compare two surgical procedures in individuals with BRCA1 mutations to assess reduced risk of ovarian cancer

The purpose of this study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for individuals with BRCA1 mutations

Age & Gender

35 years ~ 50 years
Female

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

The study involves surgery; a postoperative visit 10-60 days after your surgery; annual CA-125 testing; questionnaires to complete. The questionnaires will be completed before surgery (baseline), 6 months after surgery, 12 months after surgery, and annually thereafter.

In-person visits:
4

Phone or online visits:
1

Total length of participation:
up to 5 years

Looking for Specific Volunteers

Able to participate:

you are 35-50 years of age
you have positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1mutation in the patient. Documentation of the result is required
you had Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration.
3. You can provide study-specific informed consent prior to study entry

Not eligible if:

you have a history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any
you have prior history of ovarian cancer, including low malignant potential neoplasms (LMP),primary peritoneal carcinoma, or fallopian tube carcinoma
you have abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Olivia Lara
Obstetrics and Gynecology - Gynecologic Oncology

Study Type

Clinical or Medical
Observational

Study Topics

Cancer (Ovarian)

IRB Number

24-1413

ClinicalTrials.gov

NCT04251052

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