Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

446 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-26

Study Completion Date

2018-07-06

Brief Summary

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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 ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.

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Detailed Description

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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, primary peritoneal cancer or fallopian tube cancer because such a ratio has not yet been adequately clarified in Japan.

The newly diagnosed eligible patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer shall be asked to participate in this study in order of diagnosis. After obtaining their consents by the written informed consent following appropriate explanation, investigations about the demographic information including the cancer family history shall be performed. Subsequently, blood is collected for investigation about gBRCAm. In addition, histological classification shall be conducted based on the resected tumor tissues.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

For registration to this study, all of the following criteria should be satisfied:

1. The subject can attach the signature to the Informed Consent Form (ICF), besides having his/her intention to put the signature.
2. Female Japanese at more than 20 years of age
3. 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).
4. The histopathological specimens can be submitted to the central pathological judgment.
5. 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 Criteria

1. 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.
2. In case of the subjects whose registration for the study is judged by the attending responsible physician as inappropriate.

Minimum Eligible Age

20 Years

Maximum Eligible Age

130 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No