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Trial record 37 of 599 for:    Recruiting, Not yet recruiting, Available Studies | Ovarian cancer

China Ovarian Cancer BRCA Testing Study (CRONUS)

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ClinicalTrials.gov Identifier: NCT03203993
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : September 20, 2019
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
Estimated Enrollment : 900 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
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

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


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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China
Research Site Not yet recruiting
BeiJing, China
Research Site Not yet recruiting
Changsha, China
Research Site Not yet recruiting
Chengdu, China
Research Site Not yet recruiting
Chongqing, China
Research Site Not yet recruiting
Guangzhou, China
Research Site Not yet recruiting
Hangzhou, China
Research Site Not yet recruiting
Hefei, China
Research Site Not yet recruiting
Jinan, China
Research Site Not yet recruiting
Shanghai, China
Research Site Not yet recruiting
Suzhou, China
Research Site Not yet recruiting
Tianjin, China
Research Site Not yet recruiting
Zhengzhou, China
Hong Kong
Research Site Not yet recruiting
Hong Kong, Hong Kong
Research Site Recruiting
Hong Kong, Hong Kong
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     History of Changes
Other Study ID Numbers: D133FR00117
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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