China Ovarian Cancer BRCA Testing Study

Ovarian Cancer Clinical Trial

— CRONUS  

Official title:

China Local BRCA Testing and Exploration of Ovarian Cancer Treatment Outcomes of Different BRCA Status in Newly Diagnosed Epithelial Ovarian Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03203993
• Other study ID #: D133FR00117
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

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