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

Study Overview
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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.

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.

Official Title
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Japan CHARLOTTE: Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA

Conditions
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Ovarian Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan. | To be evaluated based on laboratory test. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ownership ratio of gBRCAm when stratified according to the patients' demographics | To be evaluated by laboratory test | Baseline | 
| Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing | To be evaluated by questionnaire | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer, gBRCAm