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

NCT ID: NCT04991051

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 605 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-02
• Study Completion Date: 2022-08-15

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.

Conditions

Fallopian Tube Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Kuwait City, , Kuwait

Research Site

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

Countries

Kuwait; Oman; Qatar; Russia; Saudi Arabia; United Arab Emirates

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D0818R00007&attachmentIdentifier=c5406519-b22f-4424-9a59-8e048f4f7f0b&fileName=CSR__D0818R00007_HALO_Final.v1.0_-_signed_Redacted.pdf&versionIdentifier=

CSR Synopsis

Other Identifiers

D0818R00007

Identifier Type: -

Identifier Source: org_study_id