PREDICT: Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region. A Prospective, Multi-centre, Epidemiological Observational Study Designed to Evaluate the Prevalence of BRCA1 and BRCA2 Mutations in Current and Newly Diagnosed Ovarian Cancer Patients Across Different Countries in the Gulf Region. This Study Study Will Also Describe the Epidemiological Features for the Disease for the Enrolled Patients.

AstraZeneca1 site in 1 country108 target enrollmentJuly 16, 2017

ConditionsOvarian Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ovarian Cancer
Sponsor: AstraZeneca
Enrollment: 108
Locations: 1
Primary Endpoint: Prevalence of somatic BRCA mutations among ovarian cancer patients
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 16, 2017

End Date

July 24, 2019

Last Updated

5 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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:
•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.

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Prevalence of somatic BRCA mutations among ovarian cancer patients

Time Frame: 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 Outcomes

Describe epidemiological characteristics(Up to 4 Weeks for BRCA testing result)
Describe treatment modalities(Up to 4 Weeks for BRCA testing result)
Associations or correspondence in prevalence between genetic alterations(Up to 4 Weeks for BRCA testing result)
Categorize epideimiological charactersitics and clinical features(Up to 4 Weeks for BRCA testing result)