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Background Patients with pathogenic sequence variants (PSVs) in  BRCA1/BRCA2  are at high risk of developing ovarian cancer (OC). However, genetic testing for  BRCA1/BRCA2  PSVs is still not a routine practice in the Middle East. With the lack of epidemiological studies in the region, we aim to describe the prevalence of  BRCA1/BRCA2  PSVs in patients with OC across different countries in the Gulf region. Methods The PREDICT study was an observational, prospective, epidemiological study, which consecutively recruited women with ovarian, primary peritoneal, and fallopian tube cancers from the following Gulf countries over the period from July 2017 to July 2019; United Arab Emirates (UAE), Kuwait, and Oman. The study was approved by the local ethics committee of participating centers. The  BRCA1/BRCA2  PSVs were assessed by tissue genetic testing using next-generation sequencing (NGS). Results A total of 105 women were included with a median age at diagnosis of 52 years (IQR 44.5 – 61.0). Nearly 11.4% of patients reported a family history of ovarian or breast cancer, while 4.7% of patients reported a family history of other cancers. Most of the patients (70.3%) had advanced disease (FIGO stage III/IV) at presentation. Eighty-eight patients (84%) were successfully tested for somatic  BRCA1/BRCA2  PSVs. Fifteen patients (17%) were found to have PSVs in either  BRCA1 ,  BRCA2 , or both genes; of them, 10 patients (11.2%) had  BRCA1  somatic PSVs alone, eight patients (9.1%) had  BRCA2  somatic PSVs, while three patients (2.9%) had both PSVs. Five patients with  BRCA1/BRCA2  somatic PSVs had germline PSVs tests, and three of them tested positive. Concerning treatment, 87.6% of patients received perioperative chemotherapy and 6.6% as first-line palliative chemotherapy. Eighty-seven (82.9%) patients underwent debulking surgery, with no residual disease in 42.5% of patients. Conclusion Our study showed that the prevalence of  BRCA1/BRCA2  somatic PSVs in patients with OC is higher than the reported global figures (2-8%). However, more studies are warranted to further elucidate the prevalence of  BRCA1/BRCA2  somatic and germline PSVs, as well as other relevant genetic alterations, to better understand their impact on OC patient outcomes in Gulf countries. Trial registration NCT03082976 .

Prevalence of BRCA1 and BRCA2 pathogenic sequence variants in ovarian cancer patients in the Gulf region: the PREDICT study