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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03203993
Other study ID # D133FR00117
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 31, 2018
Est. completion date March 31, 2020

Study information

Verified date October 2020
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 29
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 130 Years
Eligibility Inclusion Criteria:

- Be able and willing to sign the informed consent form (ICF)

- Female aged 18 years or over

- Have histologically confirmed new diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made by one or more of the following:

- standard staging laparotomy including bilateral salpingo-oophorectomy, omentectomy, and lymph node sampling and debulkingand/or

- surgical resection and radiographic evidence consistent with Stage III or IV ovarian cancer

- biopsy with radiographic evidence consistent with Stage III or IV ovarian cancer

- Have availability of paraffin-embedded archivedtumor tissue block (preferred) or,if a block is not possible, a minimum of twenty 5-µm unstained sections. (Tumor tissue should be archived at diagnosis. 10 slides is utilized for sBRCA testing after the enrolment. Another 10 slides is utilized for exploratory evaluation of HRR gene mutations in a retrospective way.)

- Have a diagnosis that is within 60 days of informed consent

Exclusion Criteria:

- Have a diagnosis of additional concurrent malignancies or previous diagnosis of another malignancy with current evidence of residual disease

- Have a diagnosis of other 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, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study

- Be currently participating in any other clinical trial for first-line treatment of ovarian cancer

- Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study

Study Design


Locations

Country Name City State
China Research Site Beijing Beijing
China Research Site Beijing Beijing
China Research Site Beijing Beijing
China Research Site Changsha Hunan
China Research Site Chengdu Sichuan
China Research Site Chongqing Chongqing
China Research Site Guangzhou Guangdong
China Research Site Guangzhou Guangdong
China Research Site Guangzhou Guangdong
China Research Site Hangzhou Zhejiang
China Research Site Hefei Anhui
China Research Site Jinan Shandong
China Research Site Shanghai Shanghai
China Research Site Shanghai Shanghai
China Research Site Tianjin Tianjin
China Research Site Tianjin Tianjin
China Research Site Wuhan Hubei
China Research Site Zhengzhou Henan
Hong Kong Research Site Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Other Proportion of newly diagnosed ovarian cancer patients with HRR gene mutations To evaluate the prevalence of homologous recombination repair (HRR) gene mutations in newly diagnosed ovarian cancer patients 1 year
Primary Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations To evaluate the prevalence of gBRCA mutation and sBRCA mutation in newly diagnosed ovarian cancer patients 1 year
Secondary Progression-free survival (PFS) To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of PFS 18 months
Secondary Overall survival (OS) To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of OS up to 5 years
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