ISRCTN93652154已完成未知
What carcinoembryonic antigen (CEA) level should trigger further investigation during colorectal cancer follow-up? - an observational diagnostic data analysis
Oxford University (UK)0 个研究点目标入组 600 人开始时间: 2013年4月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of primary colorectal cancer. Stage I-III disease
- •2. Have undergone curative resection (i.e., no residual disease [R0]). Microscopically clear margins
- •3. Complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, CT pneumocolon, or virtual colonoscopy
- •4. Post-operative blood CEA = 10 ng/mL (if the normal range is = 5 ng/mL) OR < 2 times upper limit of normal (if normal range is > 5 ng/mL). For patients undergoing adjuvant therapy, CEA should be measured after completion of chemotherapy
- •5. Has completed primary curative treatment, as deemed by hospital clinician. Patients awaiting stoma closure allowed
- •6. No evidence of metastatic disease on pre- or post-operative liver CT scan (or ultrasound) and chest CT scan (or chest x-ray)
- •7. No diagnosis of familial adenomatous polyposis (FAP) or dominantly inherited colon cancer
- •8. No concurrent serious illness
- •9. History of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up
- •10. Pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved
- •11. No concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements
- •12. Participation in the FACS trial in one of the two arms being followed-up with regular scheduled blood CEA tests.
排除标准
- •1. Did not meet inclusion criteria
- •2. Unable to give written informed consent
研究者
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