Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region
- Conditions
- Ovarian Cancer
- Registration Number
- NCT03082976
- Lead Sponsor
- AstraZeneca
- Brief Summary
A prospective, multi-centre, epidemiological observational study designed to evaluate the prevalence of BRCA1 and BRCA2 (BReast CAncer gene) mutations in current and newly diagnosed ovarian cancer patients across different countries in the Gulf region. This study will also describe the epidemiological features for the disease for the enrolled patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 108
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Subjects willing to sign the informed consent form (ICF)
-
Female subjects 18 years of age or older
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Have histologically confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) ovarian epithelial, primary peritoneal cancer made by one or more of the following:
- Standard staging laparotomy including bilateral salpingo-oophorectomy,omentectomy, and lymph node sampling and debulking and/or
- Surgical resection and radiographic evidence consistent with ovarian cancer
- Paracentesis or biopsy with radiographic evidence consistent with ovarian cancer(normal appearing pancreas, liver, and gastrointestinal tract).
-
Have availability of paraffin-embedded archived tumor tissue block (preferred) or, if a block is not possible, a minimum of twenty 10-um sections.
Patients who meet any of the following criteria are ineligible to participate in the study and hence will not be consented:
- The diagnosis is not of a primary ovarian cancer; thus, patients will be excluded if a previous cancer has metastasized to the ovary, or if there is a secondary malignancy that is associated with the ovarian cancer.
- Is not able or willing to provide written informed consent.
- Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study.
- Be a patient who, in the judgment of the Investigator, would be inappropriate for enrollment in this study.
A rationale will be documented for all patients who are screened and ultimately excluded from the study as a result of meeting any of the aforementioned exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of somatic BRCA mutations among ovarian cancer patients Up to 4 Weeks for BRCA testing result The primary objective of this study is to discern the prevalence of somatic BRCA1 and BRCA2 mutations in patients with ovarian cancer, peritoneal cancer, and fallopian tube cancer, as assessed by tissue genetic testing in tumor samples
- Secondary Outcome Measures
Name Time Method Describe epidemiological characteristics Up to 4 Weeks for BRCA testing result Describe epidemiological characteristics (e.g., age, ethnicities) of patients being treated for ovarian cancer.
Describe treatment modalities Up to 4 Weeks for BRCA testing result Describe treatment strategy among the treatment-experienced subgroup of patients who were previously diagnosed with ovarian cancer
Associations or correspondence in prevalence between genetic alterations Up to 4 Weeks for BRCA testing result Examine associations (or correspondence) in prevalence between genetic alterations in hereditary (germline) and tissue (somatic) BRCA mutations by testing for germline (blood) mutations in those patients who are known to have somatic mutations
Categorize epideimiological charactersitics and clinical features Up to 4 Weeks for BRCA testing result Describe epidemiological characteristics(e.g. Comorbidities, stage) of patients being treated for ovarian cancer
Trial Locations
- Locations (1)
Research Site
🇦🇪Al Ain, United Arab Emirates