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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 examine 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
Alabama Birmingham University of Alabama, Birmingham Cancer Center 205-934-0220    tmyrick@uab.edu   
Arizona Tucson Banner University Medical Center, Tucson  aselegue@email.arizona.edu   
Tucson University of Arizona Cancer Center-North Campus 800-327-2873  
California Antioch Kaiser Permanente-Deer Valley Medical Center 877-642-4691    Kpoct@kp.org   
Dublin Kaiser Permanente Dublin 877-642-4691 
Fremont Kaiser Permanente-Fremont 877-642-4691    Kpoct@kp.org   
Fresno Fresno Cancer Center 877-642-4691    Kpoct@kp.org   
Fresno Kaiser Permanente-Fresno 877-642-4691    Kpoct@kp.org   
Irvine Kaiser Permanente-Irvine 800-398-3996    clinical.trials@kp.org
Los Angeles Kaiser Permanente Los Angeles Medical Center 800-398-3996    clinical.trials@kp.org
Los Angeles UCLA / Jonsson Comprehensive Cancer Center 888-798-0719   
Modesto Kaiser Permanente-Modesto 877-642-4691    Kpoct@kp.org   
Oakland Kaiser Permanente Oakland-Broadway 877-642-4691    Kpoct@kp.org   
Rancho Cordova Kaiser Permanente-Rancho Cordova Cancer Center 877-642-4691    Kpoct@kp.org   
Redwood City Kaiser Permanente-Redwood City 877-642-4691    Kpoct@kp.org   
Richmond Kaiser Permanente-Richmond 877-642-4691    Kpoct@kp.org   
Riverside Kaiser Permanente-Riverside 800-398-3996    clinical.trials@kp.org
Rohnert Park Rohnert Park Cancer Center 877-642-4691    Kpoct@kp.org   
Roseville Kaiser Permanente-Roseville 877-642-4691    Kpoct@kp.org  
Roseville The Permanente Medical Group-Roseville Radiation Oncology 877-642-4691    Kpoct@kp.org  
Sacramento Kaiser Permanente Downtown Commons 877-642-4691    Kpoct@kp.org  
Sacramento Kaiser Permanente-South Sacramento 877-642-4691    Kpoct@kp.org  
Sacramento South Sacramento Cancer Center 877-642-4691    Kpoct@kp.org  
San Francisco Kaiser Permanente-San Francisco 877-642-4691    Kpoct@kp.org  
San Jose Kaiser Permanente-Santa Teresa-San Jose 877-642-4691    Kpoct@kp.org  
San Leandro Kaiser Permanente San Leandro 877-642-4691    Kpoct@kp.org  
San Rafael Kaiser San Rafael-Gallinas 877-642-4691    Kpoct@kp.org  
Santa Clara Kaiser Permanente Medical Center - Santa Clara 877-642-4691    Kpoct@kp.org 
Santa Rosa Kaiser Permanente-Santa Rosa 877-642-4691    Kpoct@kp.org 
South San Francisco Kaiser Permanente Cancer Treatment Center 877-642-4691    Kpoct@kp.org 
South San Francisco Kaiser Permanente-South San Francisco 877-642-4691    Kpoct@kp.org 
Stockton Kaiser Permanente-Stockton 877-642-4691    Kpoct@kp.org 
Vacaville Kaiser Permanente Medical Center-Vacaville 877-642-4691    Kpoct@kp.org 
Vallejo Kaiser Permanente-Vallejo 877-642-4691    Kpoct@kp.org 
Walnut Creek Kaiser Permanente-Walnut Creek 877-642-4691    Kpoct@kp.org 
Colorado Aurora University of Colorado Hospital 720-848-0650   
Colorado Springs UCHealth Memorial Hospital Central  719-365-2406   
Colorado Springs Memorial Hospital North  719-364-6700 
Highlands Ranch UCHealth Highlands Ranch Hospital 720-848-0650 
Longmont Longmont United Hospital 308-398-6518    clinicaltrials@sfmc-gi.org   
Connecticut Hartford Hartford Hospital  860-545-5363 
New Britain The Hospital of Central Connecticut 860-224-5660
Delaware Lewes Beebe Medical Center 302-645-3770    Dmiskin@Beebehealthcare.org  
Newark Delaware Clinical and Laboratory Physicians 302-623-4450     
Newark Christiana Care Health System-Christiana Hospital 302-623-4450   
Rehoboth Beach Beebe Health Campus 302-645-3770    Dmiskin@Beebehealthcare.org  
Wilmington  Christiana Care Health System-Wilmington Hospital 302-623-4450    
Georgia Atlanta Northside Hospital 404-303-3355    ClinicalTrials@northside.com   
Savannah Lewis Cancer and Research Pavilion at Saint Joseph's/Candler 912-819-5704    underberga@sjchs.org   
Hawaii Honolulu Kaiser Permanente Moanalua Medical Center 808-432-5195    shelley.a.clark@kp.org   
Illinois Aurora Copley Medical Center 630-978-6212    Cancer.Research@rushcopley.com 
Chicago University of Illinois 312-355-3046
Chicago Northwestern University 312-695-1301    cancer@northwestern.edu 
Chicago University of Chicago Comprehensive Cancer Center 773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
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
Lake Forest Northwestern Medicine Lake Forest Hospital cancertrials@northwestern.edu 
Mattoon Carle Physician Group-Mattoon/Charleston 800-446-5532    Research@carle.com
Naperville Edward Hospital/Cancer Center 630-646-6075
New Lennox UC Comprehensive Cancer Center at Silver Cross 773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Orland Park University of Chicago Medicine-Orland Park 773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Plainfield Edward Hospital/Cancer Center Plainfield 630-646-6075 Cancerresearch@edward.org
Urbana The Carle Foundation Hospital 800-446-5532    Research@carle.com 
Urbana Carle Cancer Center 800-446-5532    Research@carle.com 
Yorkville Rush-Copley Healthcare Center 630-978-6212   Cancer.Research@rushcopley.com 
Indiana Goshen Goshen Center for Cancer Care 574-364-2973    cccois@goshenhealth.com  
Iowa Iowa City University of Iowa/Holden Comprehensive Cancer Center 800-237-1225  
Kentucky Edgewood Saint Elizabeth Medical Center South 859-301-5473    darla.hehman@stelizabeth.com
Maine Portland Maine Medical Center-Bramhall Campus 207-885-7565  
Scarborough Maine Medical Center-Scarborough 207-396-8090    wrighd@mmc.org
Michigan Dearborn Beaumont Hospital - Dearborn 248-551-7695 
Detroit Wayne State University/Karmanos Cancer Institute 313-576-9790    ctoadmin@karmanos.org   
Farmington Hills Weisberg Cancer Treatment Center 313-576-9790    ctoadmin@karmanos.org   
Farmington Hills Beaumont Hospital - Farmington Hills 248-551-7695   
Kalamazoo Bronson Methodist Hospital 616-391-1230    crcwm-regulatory@crcwm.org 
Kalamazoo West Michigan Cancer Center 616-391-1230    crcwm-regulatory@crcwm.org 
Kalamazoo Borgess Medical Center 616-391-1230    crcwm-regulatory@crcwm.org 
Royal Oak William Beaumont Hospital - Royal Oak 248-551-7695
Troy William Beaumont Hospital - Troy 248-551-7695
Minnesota Burnsville Minnesota Oncology - Burnsville 952-993-1517    mmcorc@healthpartners.com 
Minneapolis Abbott Northwestern 952-993-1517    mmcorc@healthpartners.com 
Rochester Mayo Clinic 855-776-0015  
Missouri St. Louis Mercy Hospital South janet.lesko@mercy.net   
St. Louis Missouri Baptist Medical Center 314-996-5569    
St. Louis Mercy Hospital St. Louis 314-251-7066     
Springfield Mercy Hospital Springfield 417-269-4520  
Springfield CoxHealth South 417-269-4520  
Montana Billings Billings Clinic Cancer Center 800-996-2663    research@billingsclinic.org
Nebraska Omaha Nebraska Methodist Hospital 402-354-5144
Omaha Nebraska Medicine-Village Pointe 402-559-5600  
Omaha University of Nebraska Medical Center 402-559-6941    unmcrsa@unmc.edu 
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
Pennington Capital Health Medical Center-Hopewell 800-255-3440  
New Mexico Albuquerque University of New Mexico Cancer Center 505-925-0366    LByatt@nmcca.org
Rio Rancho Presbyterian Rust Medical Center/Jorgensen Cancer Center 505-559-6113    WBurman@phs.org   
New York New York Laura and Isaac Perlmutter Cancer Center at NYU Langone 212-263-4434 prmc.coordinator@nyumc.org
New York Memorial Sloan Kettering Cancer Center 212-639-7592   
Rochester Highland Hospital 585-341-8113  
Rochester University of Rochester 585-275-5830  
North Carolina Winston-Salem Wake Forest University Health Sciences 336-713-6771  
Ohio Alliance Aultman Alliance Community Hospital 330-363-1250   
Canton Aultman Health Foundation 330-363-7274    ClinicalReserachDept@aultman.com 
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
Cleveland Cleveland Clinic Cancer Center/Fairview Hospital 866-223-8100    TaussigResearch@ccf.org  
Cleveland Cleveland Clinic Foundation 866-223-8100    TaussigResearch@ccf.org  
Oklahoma Oklahoma City University of Oklahoma Health Sciences Center 405-271-8777    ou-clinical-trials@ouhsc.edu   
Oregon Clackamas Clackamas Radiation Oncology Center 503-215-2614    CanRsrchStudies@providence.org   
Clackamas Providence Cancer Institute Clackamas Clinic 503-215-2614    CanRsrchStudies@providence.org   
Newberg Providence Newberg Medical Center 503-215-2614    CanRsrchStudies@providence.org  
Portland Legacy Good Samaritan Hospital and Medical Center 800-220-4937    cancer@lhs.org 
Portland Providence Portland Medical Center 503-215-2614    CanRsrchStudies@providence.org
Portland Providence Saint Vincent Medical Center 503-215-2614    CanRsrchStudies@providence.org
Tualatin Legacy Meridian Park Hospital 503-413-1742
Pennsylvania Abington Abington Memorial Hospital Mark.Shahin@jefferson.edu   
Chadds Ford Christiana Care Health System-Concord Health Center 302-623-4450    mhayden@christianacare.org 
Philadelphia Thomas Jefferson University Hospital Mark.Shahin@jefferson.edu   
Pittsburgh University of Pittsburgh Cancer Institute (UPCI) 412-647-8073
West Chester Chester County Hospital 610-431-5297 
Willow Grove Abington Memorial Hospital-Asplundh Cancer Pavilion 215-481-2402   Mark.Shahin@jefferson.edu
Rhode Island Providence Women and Infants Hospital 401-274-1122
South Carolina Gaffney Gibbs Cancer Center-Gaffney 864-560-6104    kmertz-rivera@gibbscc.org   
Greenville Prisma Health Cancer Institute - Faris 864-522-2066    kim.williams3@prismahealth.org
Greenville Prisma Health Greenville Memorial Hospita 864-522-2066    kim.williams3@prismahealth.org
Greer Gibbs Cancer Center-Pelham 864-560-6104    kmertz-rivera@gibbscc.org   
Seneca Prisma Health Cancer Institute - Seneca 864-522-2066    kim.williams3@prismahealth.org   
Spartanburg Spartanburg Medical Center 864-560-6104    kmertz-rivera@gibbscc.org   
Union MGC Hematology Oncology-Union 864-560-6104    kmertz-rivera@gibbscc.org   
Texas Dallas UT Southwestern/Simmons Cancer Center-Dallas canceranswerline@UTSouthwestern.edu
Dallas Parkland Memorial Hospital  214-590-5582    canceranswerline@UTSouthwestern.edu
Fort Sam Houston Brooke Army Medical Center 210-916-4837 
Virginia Charlottesville University of Virginia Cancer Center 434-243-6303 PAS9E@virginia.edu
Richmond VCU Massey Cancer Center at Stony Point 804-628-1939    mwellons@vcu.edu  
Richmond Virginia Commonwealth University/Massey Cancer Center 804-628-1914    klcampbell@vcu.edu  
Washington Seattle Fred Hutchinson Cancer Research Center/University of Washington/Seattle Cancer Care Aliance 800-804-8824    gynresearch@seattlecca.org
Vancouver Legacy Salmon Creek Hospital 503-413-2150  
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

Warner Huh, MD
University of Alabama, Birmingham

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