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CRONUS: China Ovarian Cancer BRCA Testing Study

Sponsor
AstraZeneca (Industry)
Overall Status
Terminated
CT.gov ID
NCT03203993
Collaborator
(none)
29
Enrollment
19
Locations
26
Actual Duration (Months)
1.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    29 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    China Local BRCA Testing and Exploration of Ovarian Cancer Treatment Outcomes of Different BRCA Status in Newly Diagnosed Epithelial Ovarian Cancer Patients
    Actual Study Start Date :
    Jan 31, 2018
    Actual Primary Completion Date :
    Mar 31, 2020
    Actual Study Completion Date :
    Mar 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Progression-free survival (PFS) [18 months]

      To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of PFS

    2. Overall survival (OS) [up to 5 years]

      To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of OS

    Other Outcome Measures

    1. Proportion of newly diagnosed ovarian cancer patients with HRR gene mutations [1 year]

      To evaluate the prevalence of homologous recombination repair (HRR) gene mutations in newly diagnosed ovarian cancer patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Hefei Anhui China 230601
    2 Research Site Beijing Beijing China 100142
    3 Research Site Beijing Beijing China 100191
    4 Research Site Beijing Beijing China 100730
    5 Research Site Chongqing Chongqing China 400030
    6 Research Site Guangzhou Guangdong China 510060
    7 Research Site Guangzhou Guangdong China 510080
    8 Research Site Guangzhou Guangdong China 510220
    9 Research Site Zhengzhou Henan China 450008
    10 Research Site Wuhan Hubei China 430030
    11 Research Site Changsha Hunan China 410000
    12 Research Site Jinan Shandong China 250014
    13 Research Site Shanghai Shanghai China 200032
    14 Research Site Shanghai Shanghai China 200080
    15 Research Site Chengdu Sichuan China 610041
    16 Research Site Tianjin Tianjin China 300110
    17 Research Site Tianjin Tianjin China 300202
    18 Research Site Hangzhou Zhejiang China 310006
    19 Research Site Hong Kong Hong Kong 0

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Chair: Jinghe Lang, Dr, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT03203993
    Other Study ID Numbers:
    • D133FR00117
    First Posted:
    Jun 29, 2017
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    BRCA mutation
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Oct 14, 2020