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A Study to Compare Two Surgical Procedures in Women with BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer (SOROCk)

A Study to Compare Two Surgical Procedures in Women with BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer (SOROCk)

Clinicaltrials.gov identifier:
NCT04251052

Prevention:
Ovarian

Study Contact Information:

For more information, contact NRG Oncology

Phone: 267-519-6630

Email: info@nrgoncology.org

 


A Study to Compare Two Surgical Procedures in Women with BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer (SOROCk)

About the study

SOROCk [NRG-CC008] is a clinical trial studying if removal of just the fallopian tubes can reduce the risk of ovarian cancer nearly as much as removing both the ovaries and fallopian tubes among women with an inherited BRCA1 mutation. The main benefit of removing only the fallopian tubes and not the ovaries is to prevent surgically-induced menopause. The study will also exam various patient-reported quality of life outcomes. Researchers believe that most ovarian cancers first begin in the fallopian tubes, suggesting that removing the fallopian tubes only may prevent the development of ovarian cancer. This concept has never been formally testing in a clinical trial.

For more information, visit https://clinicaltrials.gov/ct2/show/NCT04251052


What the Study Entails

Here are the steps to participate in the SOROCk Study:

  • Plan for ovarian cancer surgical risk reduction with either:
    • Standard of care surgery to remove both ovaries and fallopian tubes
    • Investigational surgery to remove only the fallopian tubes with a plan to remove the ovaries at a later time
    • Completing personal and family history questionnaires
    • Have recently had a normal pelvic ultrasound and a normal CA125 blood test
    • Give consent: This step includes:
    • Reading and signing the consent form to enroll
  • Genetic testing
    • All participants must have an inherited mutation in BRCA1
  • Get test results
    • Give a copy of your genetic test results from your surgeon.
  • Follow up
    • Follow-up visits will occur after surgery and then once per year for approximately 6 to 16 years. These visits can be done with your surgeon or a local health care provider
    • All participants will be asked to complete an annual questionnaire for up to 20 years after the study. These can be completed electronically on an iphone or similar device.


Study Locations

The following are participating institutions:

State City Facility Contact Info
Delaware Lewes Beebe Medical Center 302-645-3770    Dmiskin@Beebehealthcare.org  
Newark Delaware Clinical and Laboratory Physicians 302-623-4450    KDempsey@christianacare.org   
Newark Christiana Care Health System-Christiana Hospital 302-623-4450    KDempsey@christianacare.org  
Rehoboth Beach Beebe Health Campus 302-645-3770    Dmiskin@Beebehealthcare.org  
Wilmington Hospital Christiana Care Health System-Wilmington Hospital 302-623-4450    KDempsey@christianacare.org
Illinois Aurora Copley Medical Center 630-978-6212    Cancer.Research@rushcopley.com 
Chicago University of Illinois 312-355-3046
Danville Carle on Vermillion 800-446-5532 Research@carle.com 
Effingham Carle Physician Group-Effingham 800-446-5532 Research@carle.com  
Elmhurst Elmhurst Memorial Hospital 630-758-5460    Jrohde@emhc.org
Evanston NorthShore University HealthSystem-Evanston Hospital 847-570-2109  
Glenview NorthShore University HealthSystem-Glenbrook Hospital 847-570-2109
Highland Park NorthShore University HealthSystem-Highland Park Hospital 847-570-2109
Mattoon
Carle Physician Group-Mattoon/Charleston
800-446-5532    Research@carle.com
Naperville Edward Hospital/Cancer Center 630-646-6075
Plainfield Edward Hospital/Cancer Center Plainfield 630-646-6075 Cancerresearch@edward.org
Urbana Carle Cancer Center 800-446-5532    Research@carle.com 
Yorkville Rush-Copley Healthcare Center 630-978-6212   Cancer.Research@rushcopley.com 
Montana Billings Billings Clinic Cancer Center 800-996-2663    research@billingsclinic.org
Nevada Las Vegas Women's Cancer Center of Nevada 702-693-6870  kmcwhirter@wccenter.com
New Jersey New Brunswick Rutgers Cancer Institute of New Jersey 732-235-7356
New Mexico Albuquerque University of New Mexico Cancer Center 505-925-0366    LByatt@nmcca.org
New York New York Laura and Isaac Perlmutter Cancer Center at NYU Langone 212-263-4434 prmc.coordinator@nyumc.org
Ohio Cincinnati Good Samaritan Hospital - Cincinnati 308-398-6518    clinicaltrials@sfmc-gi.org 
Cincinnati Bethesda North Hospital 308-398-6518    clinicaltrials@sfmc-gi.org
Cincinnati TriHealth Cancer Institute-Westside 308-398-6518    clinicaltrials@sfmc-gi.org 
Cincinnati TriHealth Cancer Institute-Anderson 308-398-6518    clinicaltrials@sfmc-gi.org
South Carolina Greenville Prisma Health Cancer Institute - Faris 864-522-2066    kim.williams3@prismahealth.org
Seneca Prisma Health Cancer Institute - Seneca 864-522-2066    kim.williams3@prismahealth.org   
Texas Dallas UT Southwestern/Simmons Cancer Center-Dallas canceranswerline@UTSouthwestern.edu
Virginia Charlottesville University of Virginia Cancer Center 434-243-6303 PAS9E@virginia.edu
Wisconsin Green Bay Saint Vincent Hospital Cancer Center Green Bay 920-433-8889  ewd_research_admin@hshs.org
Madison University of Wisconsin Hospital and Clinics 800-622-8922
Milwaukee Medical College of Wisconsin 414-805-3666


Study Lead Investigator

Douglas A Levine, MD
NYU Langone Perlmutter Cancer Center
New York, NY

This Study is Open To:

Women can participate if:

  • they are age 35 to 50
  • have an inherited mutation in BRCA1
  • are planning to have surgery to reduce the risk of ovarian cancer
  • are premenopausal
  • have at least one ovary and fallopian tube
This Study is Not Open To:

People are excluded if they:

  • have had prior cancer and received chemotherapy within the past 12 months, hormonal therapy in the past 90 days, or radiotherapy to abdomen or pelvis at any time
  • have a history of ovarian cancer, primary peritoneal carcinoma, or fallopian tube carcinoma
  • cannot tolerate surgery or general anesthesia
  • are pregnant or planning to become pregnant in the future