Brief Title
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
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.
Study Type
Observational
Primary Outcome
The overall percentage of patients diagnosed with positive HRD status
Secondary Outcome
Region- and country-specific percentages of patients with positive HRD status
Condition
Fallopian Tube Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
405
Start Date
May 24, 2021
Completion Date
March 31, 2022
Primary Completion Date
March 31, 2022
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Russian Federation
Location Countries
Russian Federation
Administrative Informations
NCT ID
NCT04991051
Organization ID
D0818R00007
Responsible Party
Sponsor
Study Sponsor
AstraZeneca
Study Sponsor
, ,
Verification Date
September 2021