Georgia's Online Cancer Information Center

Find A Clinical Trial

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

Status
Active
Cancer Type
Ovarian Cancer
Trial Phase
Eligibility
35 - 50 Years, Female
Study Type
Prevention
NCT ID
NCT04251052
Protocol IDs
NRG-CC008 (primary)
NRG-CC008
NRG-CC008
NCI-2019-07791
Study Sponsor
NRG Oncology

Summary

This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women 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.

Objectives

PRIMARY OBJECTIVE:
I. To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germline mutations.

SECONDARY OBJECTIVES:
I. To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES) subscale compared to women in the BSO arm.
II. To determine if health-related quality of life (QOL) (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-Menopausal Symptom Checklist [MSCL]), sexual dysfunction (Female Sexual Function Index [FSFI]), and cancer distress (Impact of Events Scale [IES]) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients.
III. To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.
IV. To assess adverse events, graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

EXPLORATORY OBJECTIVES:
I. Sexual dysfunction, as measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener and external sexual function items.
II. To estimate the cost-effectiveness of BLS compared to BSO for ovarian cancer risk reduction.
III. To determine the association between health related (HR)-QOL with menopausal symptoms, as measured by the MSCL, sexual dysfunction, as measured by FSFI/PROMIS screener and external sexual function items, and cancer distress as measured by the IES.
IV. To assess medical decision making, as measured by the Risk-Reducing Medical Decision Making (RR-MDM) survey, a targeted set of questions on risk reducing surgical treatment choice.

TRANSLATIONAL RESEARCH OBJECTIVE:
I. To bank tissue and blood biospecimens for future research (pending funding).

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery.

GROUP II: Patients undergo bilateral salpingo-oophorectomy.

After completion of study, patients are followed up at 10-60 days, 6, 12, and 24 months, and then annually for up to 20 years.

Eligibility

  1. Women 35-50 years of age, inclusive
  2. Patients who have declined or elected to defer risk-reducing salpingo-oophorectomy (RRSO) after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers (for the BLS with delayed oophorectomy arms) or patients who are undergoing RRSO (for the RRSO arm)
  3. At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one intact ovary and tube are present
  4. Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself. Documentation of the result is required
  5. Premenopausal; defined as < 12 months of amenorrhea. However, for those patients with >= 12 months of amenorrhea who may be pre-menopausal or patients with a prior hysterectomy with at least one retained ovary/tube, levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and in the premenopausal range per local institutional standards will be acceptable. Concurrently planned hysterectomy with salpingectomy for the BS group or with BSO for the BSO group is permitted
  6. Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration
  7. The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.