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China Ovarian Cancer BRCA Testing Study (CRONUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203993
Recruitment Status : Terminated (Failure to obtain HGR approval.)
First Posted : June 29, 2017
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Ovarian Cancer

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.

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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 : January 31, 2018
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer




Primary Outcome Measures :
  1. Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations [ Time Frame: 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) [ Time Frame: 18 months ]
    To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of PFS

  2. Overall survival (OS) [ Time Frame: 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 [ Time Frame: 1 year ]
    To evaluate the prevalence of homologous recombination repair (HRR) gene mutations in newly diagnosed ovarian cancer patients


Biospecimen Retention:   Samples With DNA
Whole blood, tumor tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
newly diagnosed epithelial ovarian cancer patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203993


Locations
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China, Anhui
Research Site
Hefei, Anhui, China, 230601
China, Beijing
Research Site
Beijing, Beijing, China, 100142
Research Site
Beijing, Beijing, China, 100191
Research Site
Beijing, Beijing, China, 100730
China, Chongqing
Research Site
Chongqing, Chongqing, China, 400030
China, Guangdong
Research Site
Guangzhou, Guangdong, China, 510060
Research Site
Guangzhou, Guangdong, China, 510080
Research Site
Guangzhou, Guangdong, China, 510220
China, Henan
Research Site
Zhengzhou, Henan, China, 450008
China, Hubei
Research Site
Wuhan, Hubei, China, 430030
China, Hunan
Research Site
Changsha, Hunan, China, 410000
China, Shandong
Research Site
Jinan, Shandong, China, 250014
China, Shanghai
Research Site
Shanghai, Shanghai, China, 200032
Research Site
Shanghai, Shanghai, China, 200080
China, Sichuan
Research Site
Chengdu, Sichuan, China, 610041
China, Tianjin
Research Site
Tianjin, Tianjin, China, 300110
Research Site
Tianjin, Tianjin, China, 300202
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China, 310006
Hong Kong
Research Site
Hong Kong, Hong Kong, 0
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Chair: Jinghe Lang, Dr Peking Union Medical College Hospital
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03203993    
Other Study ID Numbers: D133FR00117
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type