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

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.

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• United Arab Emirates
  • Al Ain, United Arab Emirates
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Mohammed Jaloudi, MD, Tawam Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• Redacted CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2017
• Primary Completion (Actual): July 24, 2019
• Study Completion (Actual): July 24, 2019

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: D133FR00118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No