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

Ovarian Cancer Clinical Trial

— PREDICT  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082976
• Other study ID #: D133FR00118
• Status: Completed
• Start date: July 16, 2017
• Est. completion date: July 24, 2019

Study information

• Verified date: July 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 24, 2019
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
United Arab Emirates	Research Site	Al Ain

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Redacted CSR Synopsis