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

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

Study Overview

• Status: Terminated
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • Research Site
  • Beijing
    • Beijing, Beijing, China, 100142
      • Research Site
    • Beijing, Beijing, China, 100191
      • Research Site
    • Beijing, Beijing, China, 100730
      • Research Site
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Research Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Research Site
    • Guangzhou, Guangdong, China, 510080
      • Research Site
    • Guangzhou, Guangdong, China, 510220
      • Research Site
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Research Site
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Research Site
  • Hunan
    • Changsha, Hunan, China, 410000
      • Research Site
  • Shandong
    • Jinan, Shandong, China, 250014
      • Research Site
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Research Site
    • Shanghai, Shanghai, China, 200080
      • Research Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Research Site
  • Tianjin
    • Tianjin, Tianjin, China, 300110
      • Research Site
    • Tianjin, Tianjin, China, 300202
      • Research Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

newly diagnosed epithelial ovarian cancer patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of newly diagnosed ovarian cancer patients with HRR gene mutations	To evaluate the prevalence of homologous recombination repair (HRR) gene mutations in newly diagnosed ovarian cancer patients	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 29, 2017

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: BRCA mutation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: D133FR00117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD 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.

IPD Sharing 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.

• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No