Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region

Plain-language summary

This is an observational study looking at how often BRCA1 and BRCA2 gene mutations occur in ovarian cancer patients in the Gulf region. It was open to women aged 18 and over with histologically confirmed ovarian or primary peritoneal cancer. It was conducted as an observational study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

AstraZeneca

Start date

7/16/2017

Estimated completion

7/24/2019

Countries

United Arab Emirates

Related genes

Locations

• Al Ain City, United Arab Emirates

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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 exclusion criteria