Colorectal Cancer Screening in Cancer Survivors Treated With Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- The proportion of screened patients with any polyp or any high risk polyp will be calculated.
研究概览
简要总结
The risk of colorectal cancer (CRC) is significant among cancer survivors treated with abdominal radiation therapy (RT). Further, CRC is once of the few cancers for which there is effective screening. Although some expert groups recommend early CRC screening for patients with prior abdominal RT, the effectiveness of early screening is unknown. It is also unknown if radiation-induced CRC passes through a "pre-clinical" phase in which precancerous polyps are detectable and treatable prior to becoming invasive cancers. This study will evaluate whether screening will detect pre-invasive colorectal polyps among survivors treated with RT.
详细描述
Cancer survivors meeting the COG criteria for CRC screening will undergo colonoscopy and removal of colorectal polyps. Documentation of polyp number, location and pathologic characteristics will be made. Clinical data information will also be collected at the time of patient enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 35 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asymptomatic survivors treated with ≥ 25Gy to the abdomen, pelvis or spine, or ≥ 12Gy total body radiation therapy, or ≥ 12Gy whole abdominal RT.
- •Patients who have passed ≥10 years following RT
- •Patients whose current age is 35-49.
排除标准
- •Patients with signs/symptoms suggestive of CRC or other high-risk features such as:
- •Persistent constipation for >2 weeks in the last month
- •One or more unexplained episodes of red blood in the stool in the last month
- •One or more unexplained episodes of black stool in the last month
- •Unexplained pelvic pain in the last month
- •Patients with a history of Crohn's disease or ulcerative colitis
- •Patients already taking part in a colorectal screening program defined as any colorectal screening (colonoscopy, sigmoidoscopy, fecal occult blood test) within last 5 years.
- •Patients with self-reported history of colorectal polyps.
结局指标
主要结局
The proportion of screened patients with any polyp or any high risk polyp will be calculated.
时间窗: 3 years
次要结局
- Proportion calculation/identification of: demographic/treatment influences on polyp prevalence; subgroups w/polyp prevalence >20%; pts with polyps beyond 30cm flexible sigmoidoscope; pts with adenomatous polyp(s) on colonoscopy in/outside prior RT fields(3 years)