🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Egypt / NCT04251052
Recruiting Not applicable

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

NCT04251052 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2020-09-01
Last updated
2026-08-07

Condition(s) studied

Ovarian Carcinoma

Investigational drug(s) / intervention(s)

Bilateral SalpingectomyBilateral Salpingectomy with OophorectomyBiospecimen CollectionMagnetic Resonance ImagingQuality-of-Life AssessmentQuestionnaire AdministrationTransvaginal UltrasoundUltrasound Imaging

Bilateral Salpingectomy: Undergo bilateral salpingectomy

Bilateral Salpingectomy with Oophorectomy: Undergo bilateral salpingo-oophorectomy

Biospecimen Collection: Undergo blood sample collection

Magnetic Resonance Imaging: Undergo pelvic MRI

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Transvaginal Ultrasound: Undergo transvaginal ultrasound

Ultrasound Imaging: Undergo pelvic ultrasound

Study 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

Sex
FEMALE
Min age
35 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (574)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama Recruiting
Anchorage Associates in Radiation Medicine Anchorage Alaska Recruiting
Anchorage Radiation Therapy Center Anchorage Alaska Suspended
Alaska Breast Care and Surgery LLC Anchorage Alaska Recruiting
Alaska Oncology and Hematology LLC Anchorage Alaska Recruiting
Alaska Women's Cancer Care Anchorage Alaska Recruiting
Katmai Oncology Group Anchorage Alaska Recruiting
Providence Alaska Medical Center Anchorage Alaska Recruiting
CTCA at Western Regional Medical Center Goodyear Arizona Active Not Recruiting
Banner University Medical Center - Tucson Tucson Arizona Recruiting
University of Arizona Cancer Center-North Campus Tucson Arizona Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
Kaiser Permanente-Deer Valley Medical Center Antioch California Recruiting
Tower Cancer Research Foundation Beverly Hills California Recruiting
Keck Medicine of USC Buena Park Buena Park California Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California Recruiting
Mercy Cancer Center - Carmichael Carmichael California Recruiting
Mercy San Juan Medical Center Carmichael California Recruiting
City of Hope Comprehensive Cancer Center Duarte California Recruiting
Kaiser Permanente Dublin Dublin California Recruiting
Mercy Cancer Center - Elk Grove Elk Grove California Recruiting
Kaiser Permanente-Fremont Fremont California Recruiting
Fresno Cancer Center Fresno California Suspended
Kaiser Permanente Fresno Orchard Plaza Fresno California Recruiting
Kaiser Permanente-Fresno Fresno California Recruiting
City of Hope Seacliff Huntington Beach California Recruiting
Keck Medicine of USC Huntington Beach Huntington Beach California Recruiting
City of Hope at Irvine Lennar Irvine California Recruiting
Kaiser Permanente-Irvine Irvine California Recruiting
City of Hope Antelope Valley Lancaster California Recruiting
Keck Medicine of USC Koreatown Los Angeles California Recruiting
Kaiser Permanente Los Angeles Medical Center Los Angeles California Recruiting
Los Angeles General Medical Center Los Angeles California Recruiting
USC / Norris Comprehensive Cancer Center Los Angeles California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
UCLA / Jonsson Comprehensive Cancer Center Los Angeles California Recruiting
Kaiser Permanente- Modesto MOB II Modesto California Recruiting
Kaiser Permanente-Modesto Modesto California Recruiting
Providence Queen of The Valley Napa California Recruiting
USC Norris Oncology/Hematology-Newport Beach Newport Beach California Recruiting

+ 534 more sites — see the full list on the official registry below.

More NRG Oncology trials in Egypt

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04251052 on ClinicalTrials.gov ↗ ← All trials in Egypt