Clinical trial NCT04991051: Study to Determine the Prevalence of Homologous Recombination Deficiency Among Women With Newly Diagnosed, High-grade, Serous or Endometrioid Ovarian, Primary Peritoneal, and/or Fallopian Tube Cancer
Official title: HRDx-Ovarian. A Cross-sectional, Noninterventional, Multicentre Study to Determine the Prevalence of Homologous Recombination Deficiency Among Women With Newly Diagnosed, High-grade, Serous or Endometrioid Ovarian, Primary Peritoneal, and/or Fallopian Tube Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fallopian Tube Cancer
Keywords: Cancer, HRD-testing, ovarian
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 605
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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

Detailed description: 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:

* availability of the average number patients with newly diagnosed stage III and IV serous or endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer.
* completeness of patient medical records pertaining to diagnostics and having the facility, capacity, and competence of collecting and archiving FFPE tumour tissue block(s).

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.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years of age or adults according to age of majority as defined by the local regulations;
* Willing and able to provide written informed consent for participation in the study;
* Patients with histologically confirmed new diagnosis (within past 120 days of enrolment) of high-grade (stage III or IV of FIGO classification 2014) serous or endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer;
* Patients having availability of histopathology report and FFPE archival tumour tissue block(s) collected within past 120 days of enrolment.

Exclusion Criteria:

* Patients with mucinous, clear-cell, undifferentiated carcinoma or malignant Brenner's tumour;
* Patients diagnosed with any 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 results, and those in the judgment of the investigator are not appropriate for enrolment in this study

Primary outcomes:
measure: The overall percentage of patients diagnosed with positive HRD status
timeFrame: Baseline
Secondary outcomes:
measure: Region- and country-specific percentages of patients with positive HRD status
timeFrame: Baseline
measure: Overall, region- and country-specific percentages of patients with tBRCA1m/tBRCA2m within each geographical region
timeFrame: Baseline
measure: Overall, region- and country-specific percentages of patients with GIS-positive status within each geographical region
timeFrame: Baseline
measure: Association of HRD-positive status and tBRCA1m/tBRCA2m
timeFrame: Baseline
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
facility: Research Site
city: Muscat
country: Oman
facility: Research Site
city: Doha
country: Qatar
facility: Research Site
city: Balashikha
country: Russian Federation
facility: Research Site
state: Moscow Region
city: Istra Settlement
country: Russian Federation
facility: Research Site
state: Moscow Region
city: Kolomna
country: Russian Federation
facility: Research Site
state: Moscow Region
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Belgorod
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Tyumen
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: Research Site
city: Jeddah
country: Saudi Arabia
facility: Research Site
city: Makka
country: Saudi Arabia
facility: Research Site
city: Alain
country: United Arab Emirates
facility: Research Site
Study officials:
References: