Ovarian Cancer
Conditions
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects willing to sign the informed consent form (ICF) 2. Female subjects 18 years of age or older 3. Have histologically confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) ovarian epithelial, primary peritoneal cancer made by one or more of the following: 1. Standard staging laparotomy including bilateral salpingo-oophorectomy,omentectomy, and lymph node sampling and debulking and/or 2. Surgical resection and radiographic evidence consistent with ovarian cancer 3. Paracentesis or biopsy with radiographic evidence consistent with ovarian cancer(normal appearing pancreas, liver, and gastrointestinal tract). 4. 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: 1. 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. 2. Is not able or willing to provide written informed consent. 3. 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. 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compare standards of care practices | Up to 4 Weeks for BRCA testing result | 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. |
Countries
United Arab Emirates
Outcome results
None listed