NCT03296826招募中不适用
Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年11月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Occurrence of ovarian, fallopian tube, and peritoneal carcinoma
研究概览
简要总结
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.
详细描述
- To estimate the incidence of ovarian, fallopian tube and peritoneal cancers in women carrying BRCA1/2 variants.
- To investigate risk factors concerning the development of ovarian, fallopian tube, and peritoneal cancers (loci of BRCA1/2 genetic variants, modifier genes, genetic polymorphism, hormones, and lifestyle habits.) in women carrying BRCA1/2 variants.
- To estimate the detection rates of occult cancer based on histopathological evaluations, using risk-reducing salpingo-oophorectomy (RRSO).
- To examine the risk-reducing effect of RRSO on the development of ovarian, fallopian tube, and peritoneal cancers in women carrying BRCA1/2 variants, and compare with those not undergoing RRSO.
- To identify clinicopathological features in women carrying BRCA1/2 variants who had undergone RRSO.
- To identify the appropriate interval or degree of surveillance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women carrying BRCA1/2 variants (those with either BRCA1 or BRCA2 variants, or those carrying both variants) and women carrying a variant of uncertain significance (VUS).
- •Women who have received sufficient genetic counseling at any medical institution, prior to enrollment to the study.
- •Women who provide consent should be 20 years of age or older.
- •Women who provide written consent.
排除标准
- •Women without ovarian or fallopian tube cancer at the time of informed consent.
- •Women previously diagnosed with ovarian, fallopian tube, or peritoneal cancer, and not excluding those with a personal history of breast cancer development.
- •Other individuals considered inappropriate for involvement in this study by the investigator.
研究组 & 干预措施
BRCA1/2 variant carriers
Japanese women who carry BRCA 1/2 variants.
结局指标
主要结局
Occurrence of ovarian, fallopian tube, and peritoneal carcinoma
时间窗: up to 15 years
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
次要结局
- Death from any cause(up to 15 years)
- Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period.(up to 15 years)
- Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO.(up to 15 years)
- Death from any cause, including post-RRSO period.(up to 15 years)
- Deaths from ovarian, fallopian tube, and peritoneal cancers.(up to 15 years)
- Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO.(up to 15 years)
研究者
研究点 (1)
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