Clinical trial NCT03203993: China Ovarian Cancer BRCA Testing Study
Official title: China Local BRCA Testing and Exploration of Ovarian Cancer Treatment Outcomes of Different BRCA Status in Newly Diagnosed Epithelial Ovarian Cancer Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ovarian Cancer
Keywords: BRCA mutation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-06-29
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: newly diagnosed epithelial ovarian cancer patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations
timeFrame: 1 year
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 18 months
measure: Overall survival (OS)
timeFrame: up to 5 years
Other outcomes:
measure: Proportion of newly diagnosed ovarian cancer patients with HRR gene mutations
timeFrame: 1 year
Locations:
city: Hefei
country: China
facility: Research Site
state: Anhui
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Zhengzhou
country: China
facility: Research Site
state: Henan
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Hong Kong
country: Hong Kong
facility: Research Site
Study officials:
affiliation: Peking Union Medical College Hospital
name: Jinghe Lang, Dr
role: STUDY_CHAIR
References: