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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.
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.
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| 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 |
| 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 |
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Inclusion Criteria:
For registration to this study, all of the following criteria should be satisfied:
Exclusion Criteria:
The subjects who coincide any of the following exclusion criteria are designated to be ineligible:
Female Japanese at more than 20 years of age
The newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Toru Sugiyama, MD | Iwate Medical University | Principal Investigator |
| Daisuke Aoki, MD | Keio University | Study Director |
| Takayuki Enomoto, MD. PhD. | School of Medicine, Niigata University | Study Director |
| Nobuhiro Takeshima, MD. | The Cancer Institute Hospital Of JFCR. | Study Director |
| Junzo Kigawa, MD, PhD | The Matsue City Hospital | Study Director |
| Yo Watanabe | The Tohoku Medical and Pharmaceutical University | Study Director |
| Masami Arai, MD. PhD. | The Cancer Institute Hospital Of JFCR. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aichi | Japan | ||||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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From all the eligible subjects who have already attached the signature to the written informed consent, blood samples shall be collected. By using an assigned 10-mL EDTA-added blood collecting glass tube, 7 mL of the blood is sampled. The blood samples are to be recovered together with the specified test request form by Myriad and presence or absence of gBRCAm shall be centrally determined by US Myriad Genetics. Treatments of the samples, handling procedures and recovery methods are precisely described on the testing manual.
The physician responsible for institutional study has the responsibility to notify the gBRCAm results to all the patients who underwent the tests. However, this responsibility needs not to be observed if the patients themselves refuse such a notification about gBRCAm test results. This responsibility shall be assumed by the physician responsible for institutional study in each participating institute.
Incidentally, the genetic test results of the patients should
To be evaluated by questionnaire
| Baseline |
| Akita |
| Japan |
| Research Site | Aomori | Japan |
| Research Site | Chiba | Japan |
| Research Site | Fukuoka | Japan |
| Research Site | Fukushima | Japan |
| Research Site | Gifu | Japan |
| Research Site | Hyōgo | Japan |
| Research Site | Ibaraki | Japan |
| Research Site | Izumo | Japan |
| Research Site | Kanagawa | Japan |
| Research Site | Kumamoto | Japan |
| Research Site | Kyoto | Japan |
| Research Site | Maebashi | Japan |
| Research Site | Matsuyama | Japan |
| Research Site | Mie | Japan |
| Research Site | Miyagi | Japan |
| Research Site | Morioka | Japan |
| Research Site | Nagano | Japan |
| Research Site | Nagasaki | Japan |
| Research Site | Nara | Japan |
| Research Site | Niigata | Japan |
| Research Site | Okayama | Japan |
| Research Site | Okinawa | Japan |
| Research Site | Osaka | Japan |
| Research Site | Saga | Japan |
| Research Site | Saitama | Japan |
| Research Site | Sapporo | Japan |
| Research Site | Sendai | Japan |
| Research Site | Tochigi | Japan |
| Research Site | Tokushima | Japan |
| Research Site | Tokyo | Japan |
| Research Site | Tottori | Japan |
| Research Site | Tōon | Japan |
| Research Site | Yamagata | Japan |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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