NCT04251052 A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
| NCT ID | NCT04251052 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NRG Oncology |
| Condition | Ovarian Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,956 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2047-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,956 participants in total. It began in 2020-09-01 with a primary completion date of 2047-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Individuals 35-50 years of age, inclusive * Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted * At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present * Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required * Patients may be premenopausal or menopausal * Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is acceptable) or pelvic MRI and CA-125 within 180 days of registration * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry * Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future Exclusion Criteria: * Individuals with a history of any prior cancer who have received cytotoxic chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time. Endocrine therapy or maintenance ERBB2/HER2 targeted therapy is allowed. Maintenance immune checkpoint inhibitor therapy is allowed. Maintenance therapy with PARP in inhibitor is allowed. * Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma * Patients medically unfit for the planned surgical procedure * Patients with abnormal screening tests (pelvic ultrasound, pelvic MRI, CA-125) suspicious for occult or gross pelvic malignancy within the past 180 days * An abnormal pelvic ultrasound (or pelvic MRI) is defined as morphologic or structural variations suspicious for ovarian malignancy. Complex cystic lesions felt to represent a benign lesion are not exclusionary. Simple cysts of any size are not exclusionary * An abnormal CA-125 is defined as a level \> 50U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level \> 40U/ml for premenopausal individuals who are current users of oral contraceptives (Skates 2011). An abnormal CA-125 is defined as a level \> 35 U/ml in postmenopausal individuals
Contact & Investigator
Kathryn P Pennington
PRINCIPAL INVESTIGATOR
NRG Oncology
Frequently Asked Questions
Who can join the NCT04251052 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 50 Years, studying Ovarian Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04251052 currently recruiting?
Yes, NCT04251052 is actively recruiting participants. Visit ClinicalTrials.gov or contact NRG Oncology to inquire about joining.
Where is the NCT04251052 trial being conducted?
This trial is being conducted at Birmingham, United States, Anchorage, United States, Anchorage, United States, Anchorage, United States and 11 additional locations.
Who is sponsoring the NCT04251052 clinical trial?
NCT04251052 is sponsored by NRG Oncology. The principal investigator is Kathryn P Pennington at NRG Oncology. The trial plans to enroll 1,956 participants.