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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of somatic BRCA mutations among ovarian cancer patients | 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 | Up to 4 Weeks for BRCA testing result |
| Measure | Description | Time Frame |
|---|---|---|
| Associations or correspondence in prevalence between genetic alterations | 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 | Up to 4 Weeks for BRCA testing result |
| Measure | Description | Time Frame |
|---|---|---|
| Compare standards of care practices | An exploratory objective is to compare standards of care and pre- and post-diagnosis practices in each country, for example, with respect to tissue collection, processing, storage and maintenance, which is of great importance to future studies building on the present study. | Up to 4 Weeks for BRCA testing result |
Inclusion Criteria:
Subjects willing to sign the informed consent form (ICF)
Female subjects 18 years of age or older
Have histologically confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) ovarian epithelial, primary peritoneal cancer made by one or more of the following:
Have availability of paraffin-embedded archived tumor tissue block (preferred) or, if a block is not possible, a minimum of twenty 10-um sections.
Exclusion Criteria:
Patients who meet any of the following criteria are ineligible to participate in the study and hence will not be consented:
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
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The target study population will be women at least 18 years of age with histologically confirmed ovarian, peritoneal, and fallopian tube cancers at participating oncology hospitals/departments in the Gulf region. Patients enrolled in this study will be assigned to either the treatment-experienced subgroup for those who were previously diagnosis and are undergoing treatment at the time of enrollment, or the treatment-native group for those who were recently diagnosed and not yet undergoing treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed Jaloudi, MD | Tawam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Al Ain City | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34930165 | Derived | Azribi F, Abdou E, Dawoud E, Ashour M, Kamal A, Al Sayed M, Burney I. Prevalence of BRCA1 and BRCA2 pathogenic sequence variants in ovarian cancer patients in the Gulf region: the PREDICT study. BMC Cancer. 2021 Dec 20;21(1):1350. doi: 10.1186/s12885-021-09094-8. |
| Label | URL |
|---|---|
| Redacted CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Describe epidemiological characteristics | Describe epidemiological characteristics (e.g., age, ethnicities) of patients being treated for ovarian cancer. | Up to 4 Weeks for BRCA testing result |
| Describe treatment modalities | Describe treatment strategy among the treatment-experienced subgroup of patients who were previously diagnosed with ovarian cancer | Up to 4 Weeks for BRCA testing result |
| Categorize epideimiological charactersitics and clinical features | Describe epidemiological characteristics(e.g. Comorbidities, stage) of patients being treated for ovarian cancer | Up to 4 Weeks for BRCA testing result |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |