Status:
COMPLETED
Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA
Lead Sponsor:
AstraZeneca
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
20-130 years
Brief Summary
The multi-centered, cross-sectional investigations shall be conducted in this study with the objective of identifying the ownership ratio of gBRCAm on the newly diagnosed patients with epithelial ovar...
Detailed Description
This multi-centered, cooperative and epidemiological observation study is so designed to investigate the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, prima...
Eligibility Criteria
Inclusion
- For registration to this study, all of the following criteria should be satisfied:
- The subject can attach the signature to the Informed Consent Form (ICF), besides having his/her intention to put the signature.
- Female Japanese at more than 20 years of age
- The newly diagnosed patients whose epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer is histologically confirmed as FIGO from the subject to obtain their utmost understandings. Limited to histopathological diagnosis based on resected tumor specimens (except the cytodiagnosis by ascites paracentesis).
- The histopathological specimens can be submitted to the central pathological judgment.
- Within 60 days after diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, the patient's written consent has been obtained.
Exclusion
- The subjects who coincide any of the following exclusion criteria are designated to be ineligible:
- In case of the subjects who are diagnosed to have acute or chronic physical or severe mental diseases except cancer, and about whom the attending responsible physician makes judgement to say that participation of these subjects would possibly increase the risks or would probably disturb the interpretation of the study results.
- In case of the subjects whose registration for the study is judged by the attending responsible physician as inappropriate.
Key Trial Info
Start Date :
December 26 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 6 2018
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT03229122
Start Date
December 26 2016
End Date
July 6 2018
Last Update
June 10 2019
Active Locations (35)
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1
Research Site
Aichi, Japan
2
Research Site
Akita, Japan
3
Research Site
Aomori, Japan
4
Research Site
Chiba, Japan