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Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients (CHRISTELLE)

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ClinicalTrials.gov Identifier: NCT04222465
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date January 7, 2020
First Posted Date January 10, 2020
Last Update Posted Date April 1, 2020
Actual Study Start Date March 19, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 7, 2020)
The prevalence of tBRCAm in the newly diagnosed advanced OC patients [ Time Frame: Baseline ]
For BRCA1 and BRCA2 mutations detected by Myriad myChoice HRD, the number and percentage of patients with the following results will be indicated; deleterious mutation / suspected deleterious / variant of uncertain significance (VUS) / favour polymorphism / no mutation detected
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 7, 2020)
  • The prevalence of gBRCAm in the subjects [ Time Frame: Baseline ]
    For BRCA1 and BRCA2 mutations detected by BRACAnalysis, the number and percentage of patients with the following results will be indicated; deleterious mutation / suspected deleterious / variant of uncertain significance (VUS) / favour polymorphism / no mutation detected
  • The prevalence of sBRCAm in the subjects [ Time Frame: Baseline ]
    For BRCA1 and BRCA2 mutations detected by BRACAnalysis and Myriad myChoice HRD, the number and percentage of patients with the following results will be indicated; deleterious mutation / suspected deleterious
  • The ratio of sBRCAm out of tBRCAm [ Time Frame: Baseline ]
    Calculate the rate of sBRCAm out of tBRCAm
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 7, 2020)
tBRCA variant description [ Time Frame: Baseline ]
BRCA1 and BRCA2 variants detected by Myriad myChoice HRD (location and type of mutation) will be described.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients
Official Title Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients
Brief Summary

This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially.

In this study, data of 200 subjects will be collected at approximately 20 sites in Japan. To reduce regional bias of study sites, the number of enrolled patients per site will be capped.

Detailed Description

Study design:This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially.

In this study, data of 200 subjects will be collected at approximately 20 sites in Japan. To reduce regional bias of study sites, the number of enrolled patients per site will be capped.

Study population:Patients with FIGO stage III - IV epithelial ovarian cancer Drug exposure:Not applicable Planned study sites and sample size:The objective number of patients will be 200 from approximately 20 hospitals.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

This is a Japanese, multi-center, observational study. Patients with newly diagnosed FIGO stage III - IV OC after 1st January, 2019 will be enrolled sequentially.

Patients those who have undergone or are planning to undergo BRACAnalysis, which detects BRCA mutations, are eligible for this study. In this study, data of 200 subjects will be collected at approximately 20 sites in Japan. To reduce regional bias of study sites, the number of enrolled patients per site will be capped.

Condition Ovarian Neoplasms
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 7, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Aged 20 years or older of Japanese women at the time of consent (the age of death, in case of dead patient)
  • Newly diagnosed as advanced OC (FIGO stage III - IV) with epithelial ovarian cancer, primary peritoneal cancer or fallopian-tube cancer [or a combination of these cancers] after January 1, 2019
  • Patients who have archived formalin-fixed paraffin-embedded (FFPE) samples of primary or peritoneal metastatic tumor collected after January 1, 2019
  • Patients who have undergone or are scheduled to undergo BRACAnalysis
  • Patients who give their written informed consent to participate in this study (However, the cases of death should be handled in accordance with the instructions of the Ethical Review Board of each site.)

Exclusion Criteria:

  • Patients who are not recommended enrolling this study decided by physician
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Inclusion Criteria: Aged 20 years or older of Japanese women at the time of consent (the age of death, in case of dead patient)
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04222465
Other Study ID Numbers D0817R00018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators Not Provided
PRS Account AstraZeneca
Verification Date March 2020