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Procedure
Surgical Procedures for Reducing Ovarian Cancer Risk (SOROCk Trial)
N/A
Recruiting
Led By Douglas A Levine
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals 35-50 years of age, inclusive
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 years
Awards & highlights
SOROCk Trial Summary
This trial compares two surgical procedures for reducing the risk of ovarian cancer in women with BRCA1 mutations.
Who is the study for?
This trial is for women aged 35-50 with a BRCA1 mutation, who are considering or have deferred risk-reducing surgery of the fallopian tubes and ovaries. They must be medically fit for surgery, not currently have ovarian cancer, and understand they can't naturally conceive post-surgery.Check my eligibility
What is being tested?
The study compares two surgeries to lower ovarian cancer risk in women with BRCA1 mutations: removal of both fallopian tubes (bilateral salpingectomy) and removal of both tubes and ovaries (salpingo-oophorectomy). It includes quality-of-life assessments and regular ultrasounds.See study design
What are the potential side effects?
Surgical side effects may include pain, bleeding, infection risks, hormonal changes from ovary removal leading to early menopause symptoms like hot flashes or bone density loss. Emotional impacts due to infertility could also occur.
SOROCk Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 35 and 50 years old.
Select...
I have a confirmed BRCA1 mutation.
Select...
I am a woman aged between 35 and 50.
SOROCk Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 20 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers
Secondary outcome measures
Cancer distress
Estrogen deprivation symptoms (pre-menopaused patients only)
Health-related quality of life (QOL)
+4 moreOther outcome measures
Cost effectiveness
Health related (HR)-QOL
Risk-reducing medical decision making validation and assessment
+1 moreSOROCk Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (bilateral salpingectomy)Experimental Treatment5 Interventions
Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a transvaginal ultrasound during screening and blood sample collection throughout the trial.
Group II: Group II (bilateral salpingo-oophorectomy)Active Control5 Interventions
Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a transvaginal ultrasound during screening and blood sample collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bilateral Salpingectomy
2017
N/A
~40
Biospecimen Collection
2004
Completed Phase 2
~1730
Transvaginal Ultrasound
2021
Completed Phase 4
~1000
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
231 Previous Clinical Trials
98,590 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,655 Previous Clinical Trials
40,930,957 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
Douglas A LevinePrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chosen not to undergo or to delay surgery to remove my ovaries and fallopian tubes despite being at high risk due to BRCA1 mutation.I've had abnormal pelvic screening results in the last 6 months.I am between 35 and 50 years old.I am not healthy enough for my planned surgery.I am pregnant or planning to get pregnant using assisted methods and understand I can't get pregnant naturally after this.I am either before or after menopause.I have a confirmed BRCA1 mutation.I have at least one ovary and fallopian tube, or had a hysterectomy without removing both tubes.I have had ovarian, peritoneal, or fallopian tube cancer before.I am premenopausal or have hormone levels indicating I might be, despite having a hysterectomy.My ultrasound showed signs of ovarian cancer or complex cysts.I am having surgery to lower my risk of ovarian cancer due to BRCA1 mutation.I am a woman aged between 35 and 50.I have at least one ovary and fallopian tube, and haven't had both tubes removed.I have had cancer before and received chemotherapy in the last 30 days or radiation to my abdomen or pelvis at any time.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (bilateral salpingectomy)
- Group 2: Group II (bilateral salpingo-oophorectomy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the eligibility requirements for joining this research project?
"This trial is seeking a total of 2262 participants, all between 35 and 50 years old, that have been diagnosed with ovarian carcinoma."
Answered by AI
Are any individuals being accepted for this testing protocol presently?
"Clinicaltrials.gov indicates that this trial is presently in the process of recruiting patients, having been first published on June 23rd 2020 and amended most recently on June 1st 2022."
Answered by AI
Is this research project targeting participants below the age of seventy?
"Those hoping to be a part of this trial must fall within the 35-50 age bracket. Additionally, there are two other trials that accept participants below 18 years old and another 39 studies recruiting patients over 65."
Answered by AI
How many participants are currently involved with this research endeavor?
"To make this research a success, 2262 participants that meet the criteria need to be recruited. Locations with available clinical trial sites include Baptist Health Floyd in New Albany, Indiana and Aurora Cancer Care-Racine in Racine, Wisconsin."
Answered by AI
In how many distinct locations is this clinical experiment being conducted?
"This study is seeking to recruit 100 patients, with sites such as Aurora Cancer Care-Racine in Racine, Baptist Health Floyd in New Albany, and Carle Physician Group-Effingham in Effingham amongst other participating locations."
Answered by AI
Who else is applying?
What state do they live in?
Alberta
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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