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

NCT03082976 | Completed

• 1 other identifier: D133FR00118
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Associations or correspondence in prevalence between genetic alterations

  Up to 4 Weeks for BRCA testing result

• Describe epidemiological characteristics

  Up to 4 Weeks for BRCA testing result

• Describe treatment modalities

  Up to 4 Weeks for BRCA testing result

• Categorize epideimiological charactersitics and clinical features

  Up to 4 Weeks for BRCA testing result

Other Outcomes (1)

• Compare standards of care practices

  Up to 4 Weeks for BRCA testing result

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Al Ain City, United Arab Emirates

Location

Related Publications (1)

• 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.

  PMID: 34930165 DERIVED

Related Links

• Redacted CSR Synopsis

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Mohammed Jaloudi, MD

  Tawam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 17, 2017
• Study Start: July 16, 2017
• Primary Completion: July 24, 2019
• Study Completion: July 24, 2019
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)