China Ovarian Cancer BRCA Testing Study

Terminated

• Conditions: Ovarian Cancer

• Registration Number: NCT03203993
• Lead Sponsor: AstraZeneca

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-29
• Study Start: 2018-01-31
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 29

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations	1 year	To evaluate the prevalence of gBRCA mutation and sBRCA mutation in newly diagnosed ovarian cancer patients

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	up to 5 years	To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of OS
Progression-free survival (PFS)	18 months	To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of PFS

Trial Locations

Locations (1)

Research Site; 🇭🇰 Hong Kong, Hong Kong