Study identifier:D133FR00117
ClinicalTrials.gov identifier:NCT03203993
EudraCT identifier:N/A
CTIS identifier:N/A
China local BRCA testing and exploration of ovarian cancer treatment outcomes of different BRCA status in newly diagnosed epithelial ovarian cancer patients
ovarian cancer
N/A
No
-
Female
29
Observational
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: -
Verified 01 Oct 2020 by AstraZeneca
AstraZeneca
-
This is a prospective, multi-center, observational study, the primary objective is to evaluate the prevalence of gBRCA/sBRCAm in newly diagnosed ovarian cancer patients and explore ovarian cancer treatment outcomes of different BRCAm status
This is a prospective, multi-center, observational study that will enroll consecutive patients with a confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or peritoneal cancer and who consent to a blood draw, a tissue sample analysis, and follow up for collection of data. 900 newly diagnosed ovarian cancer patients will be enrolled and evaluated for Breast Cancer Susceptibility genes BRCA1 and BRCA2 germline and somatic mutations (BRCAm). Approximately 170 BRCAm positive patients and 170 negative patients will be followed in the Follow-up Period. This study aims to answer very important questions regarding the prevalence of gBRCAm and sBRCAm in a population of newly diagnosed ovarian cancer patients, and the relationship of these mutations to patient treatment and clinical outcomes. These answers may be extremely helpful in the counseling and treatment of genetic risk in these populations and may aid in making treatment decisions in the future.
Location
Location
Beijing, Beijing, China, 100730
Location
Shanghai, Shanghai, China, 200080
Location
Chengdu, Sichuan, China, 610041
Location
Tianjin, Tianjin, China, 300110
Location
Shanghai, Shanghai, China, 200032
Location
Hangzhou, Zhejiang, China, 310006
Location
Tianjin, Tianjin, China, 300202
Location
Jinan, Shandong, China, 250014
Arms | Assigned Interventions |
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