Study Stopped
Failure to obtain HGR approval.
China Ovarian Cancer BRCA Testing Study
CRONUS
China Local BRCA Testing and Exploration of Ovarian Cancer Treatment Outcomes of Different BRCA Status in Newly Diagnosed Epithelial Ovarian Cancer Patients
1 other identifier
observational
29
2 countries
19
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2018
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2017
CompletedFirst Posted
Study publicly available on registry
June 29, 2017
CompletedStudy Start
First participant enrolled
January 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedOctober 14, 2020
October 1, 2020
2.2 years
June 23, 2017
October 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Progression-free survival (PFS)
18 months
Overall survival (OS)
up to 5 years
Other Outcomes (1)
Proportion of newly diagnosed ovarian cancer patients with HRR gene mutations
1 year
Eligibility Criteria
newly diagnosed epithelial ovarian cancer patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (19)
Research Site
Hefei, Anhui, 230601, China
Research Site
Beijing, Beijing Municipality, 100142, China
Research Site
Beijing, Beijing Municipality, 100191, China
Research Site
Beijing, Beijing Municipality, 100730, China
Research Site
Chongqing, Chongqing Municipality, 400030, China
Research Site
Guangzhou, Guangdong, 510060, China
Research Site
Guangzhou, Guangdong, 510080, China
Research Site
Guangzhou, Guangdong, 510220, China
Research Site
Zhengzhou, Henan, 450008, China
Research Site
Wuhan, Hubei, 430030, China
Research Site
Changsha, Hunan, 410000, China
Research Site
Jinan, Shandong, 250014, China
Research Site
Shanghai, Shanghai Municipality, 200032, China
Research Site
Shanghai, Shanghai Municipality, 200080, China
Research Site
Chengdu, Sichuan, 610041, China
Research Site
Tianjin, Tianjin Municipality, 300110, China
Research Site
Tianjin, Tianjin Municipality, 300202, China
Research Site
Hangzhou, Zhejiang, 310006, China
Research Site
Hong Kong, 0, Hong Kong
Biospecimen
Whole blood, tumor tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jinghe Lang, Dr
Peking Union Medical College Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2017
First Posted
June 29, 2017
Study Start
January 31, 2018
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca has a long-standing commitment to making information about our clinical research publicly available. We believe that transparency enhances the scientific understanding of how our medicines work and is in the medical interest of our patients. We publish information on the registration and results of all new and ongoing AstraZeneca sponsored clinical trials for all products in all phases, including marketed medicines, drugs in development and drugs whose further development has been discontinued. We post results, irrespective of whether they are favourable or unfavourable to AstraZeneca.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.