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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

Must not have

Patients medically unfit for the planned surgical procedure

Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 20 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 35 and 50 years old.

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I have a confirmed BRCA1 mutation.

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I am a woman aged between 35 and 50.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not healthy enough for my planned surgery.

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I have had ovarian, peritoneal, or fallopian tube cancer before.

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I have had cancer before and received chemotherapy in the last 30 days or radiation to my abdomen or pelvis at any time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 20 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 20 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers

Secondary study objectives

Cancer distress

Estrogen deprivation symptoms (pre-menopaused patients only)

Health-related quality of life (QOL)

+4 more

Other study objectives

Cost effectiveness

Health related (HR)-QOL

Risk-reducing medical decision making validation and assessment

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (bilateral salpingectomy)Experimental Treatment6 Interventions

Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial.

Group II: Group II (bilateral salpingo-oophorectomy)Active Control6 Interventions

Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ultrasound Imaging

2018

Completed Phase 4

~760

Bilateral Salpingectomy

2017

N/A

~40