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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000028740 | Registry Identifier | UMIN-CTR |
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| Name | Class |
|---|---|
| Okayama University | OTHER |
| Japanese Gynecologic Oncology Group | OTHER |
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To determine the incidence and risk factors in the development of ovarian, fallopian tube, and peritoneal cancers in Japanese women carrying Breast Cancer Susceptibility Gene (BRCA)1/2 variants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRCA1/2 variant carriers | Japanese women who carry BRCA 1/2 variants. |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of ovarian, fallopian tube, and peritoneal carcinoma | Occurrence of ovarian, fallopian tube, and peritoneal carcinoma is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct | up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO. | Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct. The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO. |
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Inclusion Criteria:
Exclusion Criteria:
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BRCA1 and/or BRCA2 variant carriers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Akira Hirasawa, M.D., Ph.D. | Contact | +81-86-235-7436 | hir-aki45@umin.org |
| Name | Affiliation | Role |
|---|---|---|
| Akira Hirasawa, M.D., Ph.D. | Okayama University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Okayama University | Recruiting | Okayama | Japan |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Blood samples (all subjects) for Germ-line DNA sequencing, Biospy samples(when subjects have RRSO within follow-up duration)
| up to 15 years |
| Death from any cause | Death from any cause is a duration from the date of enrollment to the date of death from any cause. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct. | up to 15 years |
| Deaths from ovarian, fallopian tube, and peritoneal cancers. | Deaths from ovarian, fallopian tube, and peritoneal cancers is a duration from the date of enrollment to the date of death from these cancers. If the subjects have undergone RRSO, the term is defined from the date of enrollment to the date of RRSO undergone. | up to 15 years |
| Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO. | The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO. | up to 15 years |
| Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period. | Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal cancer, including in the post-RRSO period. | up to 15 years |
| Death from any cause, including post-RRSO period. | Death from any cause, including post-RRSO period is a duration from the date of enrollment to the date of death from any cause, including in the post-RRSO period. | up to 15 years |
| 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 |
| D005184 | Fallopian Tube Diseases |