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To maximise the accessibility and benefit of PARP inhibitors to eligible patients, it is essential to know the prevalence of HRD in women with advanced high-grade serous or endometrioid ovarian cancer. Presently, the prevalence data for HRD are available from selected geographies only and range from 31% to 50%. Furthermore, the risk factors associated with HRD and clinical characteristics of patients with HRD need exploration for region-specific differences. In the present study, we will estimate the region- and country-specific prevalence of HRD in women with stage III or IV high-grade serous or endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer and associated risk factors with clinical characteristics in Asia-Pacific countries, Latin America, Africa, Russia, Australia, and Middle East countries.
The findings of the study will help the oncologists in optimal patient selection and clinical decision-making for the first-line maintenance of patients with HGSOC
This cross-sectional, noninterventional, multicentre, epidemiological, observational study is designed to determine the prevalence of HRD in patients with newly diagnosed high-grade serous or endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer. The study will also determine the prevalence of tBRCA1m/tBRCA2m, genomic instability, and identify the associated risk factors in several countries across broad geographic regions. The patients with newly diagnosed high-grade (stage III or IV of Federation of Gynecology and Obstetrics [FIGO] classification 2014, Prat J, 2015) ovarian cancer, having the availability of formalin-fixed paraffin-embedded (FFPE) archival tumour tissue block(s) collected within past 120 days will be screened to enrol a minimum of 405 women after obtaining written informed consent and eligibility assessment. The FFPE tumour tissue block(s) collected as part of routine clinical care at public or private ovarian cancer management and or diagnostic facilities in the selected countries will be sent for testing at Myriad Genetics laboratories Inc.
at Salt Lake City, United States of America (USA) through Myriad's local logistics network.
This study will have a single visit.
The study centres and the respective investigators will be selected through a site-level feasibility process after assessing the following:
Assessment and selection of study centres by the study sponsor AstraZeneca (AZ) will be an ongoing process during the entire course of the study until completion of recruitment.
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| Measure | Description | Time Frame |
|---|---|---|
| The overall percentage of patients diagnosed with positive HRD status | At baseline of this study | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Region- and country-specific percentages of patients with positive HRD status | At baseline of this study | Baseline |
| Overall, region- and country-specific percentages of patients with tBRCA1m/tBRCA2m within each geographical region |
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Inclusion Criteria:
Exclusion Criteria:
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Women with high-grade (stage III or IV of FIGO classification 2014) ovarian cancer will be eligible for inclusion into the study if they meet all of the inclusion criteria and none of the exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Kuwait City | Kuwait | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41639797 | Derived | Shash E, Vardar MA, Taskiran C, Boujassoum S, Riromar J, Aboutaleb A, Sadek F, Samy E, Bahaj W. Homologous recombination deficiency in newly diagnosed advanced ovarian cancer across nine Middle East countries: prevalence, real-world testing pathways, and treatment implications. BMC Cancer. 2026 Feb 4;26(1):296. doi: 10.1186/s12885-025-15537-3. | |
| 41575336 |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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At baseline of this study
| Baseline |
| Overall, region- and country-specific percentages of patients with GIS-positive status within each geographical region | At baseline of this study | Baseline |
| Association of HRD-positive status and tBRCA1m/tBRCA2m | At baseline of this study | Baseline |
| Muscat |
| Oman |
| Research Site | Doha | Qatar |
| Research Site | Balashikha | Moscow Oblast | Russia |
| Research Site | Istra Settlement | Moscow Oblast | Russia |
| Research Site | Kolomna | Moscow Oblast | Russia |
| Research Site | Arkhangelsk | Russia |
| Research Site | Belgorod | Russia |
| Research Site | Chelyabinsk | Russia |
| Research Site | Irkutsk | Russia |
| Research Site | Krasnoyarsk | Russia |
| Research Site | Moscow | Russia |
| Research Site | Nizhny Novgorod | Russia |
| Research Site | Rostov-on-Don | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Tomsk | Russia |
| Research Site | Tula | Russia |
| Research Site | Tyumen | Russia |
| Research Site | Ufa | Russia |
| Research Site | Yaroslavl | Russia |
| Research Site | Yuzhno-Sakhalinsk | Russia |
| Research Site | Jeddah | Saudi Arabia |
| Research Site | Mecca | Saudi Arabia |
| Research Site | Alain | United Arab Emirates |
| Liou WS, Chao A, Sheu BC, Yeh LS, Wu CH. Prevalence of homologous recombination deficiency in ovarian, primary peritoneal, and/or fallopian tube cancer: results from HALO-Taiwan subset. J Gynecol Oncol. 2026 May;37(3):e55. doi: 10.3802/jgo.2026.37.e55. Epub 2025 Dec 29. |
| 40064569 | Derived | Khokhlova S, Alnaqqash MA, Bahaj W, Bujassoum S, Lee J, Mokhtar M, Tyulyandina A, Vargas Malaga CL, Wu CH. Prevalence of homologous recombination deficiency among women with newly diagnosed ovarian, primary peritoneal, and/or fallopian tube cancer: the international HALO study. Int J Gynecol Cancer. 2025 Jul;35(7):101645. doi: 10.1016/j.ijgc.2025.101645. Epub 2025 Jan 17. |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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