NCT00033488已完成不适用
The UK Familial Ovarian Cancer Screening Study
University College London Hospitals4 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2000年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,000
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer.
PURPOSE: Screening trial to determine the best procedure to detect ovarian cancer in women who have a high genetic risk for developing ovarian cancer.
详细描述
OBJECTIVES:
- Determine an optimal screening procedure for ovarian cancer, in terms of the most appropriate screening test, criteria for interpretation of results, and screening intervals, in women at high genetic risk for developing ovarian cancer.
- Determine the physical morbidity and the resource implications associated with ovarian cancer screening in these women.
- Assess the feasibility of screening this high-risk population in terms of compliance rates.
OUTLINE: Patients undergo transvaginal ultrasonography of the ovaries (scheduled for the early follicular phase, day 3-6 of the menstrual cycle) and CA 125 measurement annually. Blood samples are collected every 4 months for analysis of CA 125 levels and novel markers.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Screening
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •First-degree relative (mother, sister, or daughter) of an affected member of a high-risk family defined as one of the following:
- •Family containing 2 or more individuals with ovarian cancer who are connected by first-degree relationships
- •Family containing 1 individual with ovarian cancer and 1 individual with breast cancer and under 50 years of age at the time of diagnosis who are connected by first-degree relationships
- •Family containing 1 individual with ovarian cancer and 2 individuals with breast cancer and under 60 years of age at the time of diagnosis who are connected by first-degree relationships
- •Family containing an affected individual with a mutation of one of the known ovarian cancer predisposing genes
- •Family containing 3 individuals with colorectal cancer with at least 1 individual under 50 years of age at time of diagnosis and 1 individual with ovarian cancer who are connected by first-degree relationships
- •Families where affected relatives are related by second-degree relationships through an unaffected intervening male relative who has an affected daughter are allowed
- •PATIENT CHARACTERISTICS:
- •35 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •No prior bilateral oophorectomy
- •No concurrent participation in other ovarian cancer screening trials
排除标准
- 未提供
研究者
研究点 (4)
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