Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- differential expression of early seric biomarkers between good and bad responders.
研究概览
简要总结
Treatment for locally-advanced rectal adenocarcinoma includes preoperative radiochemotherapy before surgery with total mesorectal excision in order to reduce tumor infiltration, facilitate oncologic surgery and improve survival. About fifty percent of these patients are good responders i.e. their tumor infiltration reduces in the rectal wall and regional lymph nodes in order to be graded ypT0 to T2 N0 after pathologic assessment (so called downstaging). At the opposite, bad responders (ypT3-4 and/or N+) are not sensitive to standard preoperative radiochemotherapy, and their survival is poor than good responders. Until now, response to preoperative radiochemotherapy cannot be anticipated before pathological assessment of surgical specimen. Proteomic analysis of sera from good and bad responders to preoperative radiochemotherapy could allow identification of early biomarkers of tumor response, and subsequently adaptation of treatment to increase preoperative treatment efficiency and survival in most patients.
详细描述
Good or bad responders to preoperative radiochemotherapy for locally-advanced rectal adenocarcinoma cannot be anticipated before pathological assessment of rectal specimen. The purpose of this prospective monocentric study is to look for early seric biomarkers predictive of tumor response (good and bad responders) in patients treated by preoperative radiochemotherapy (45 Gy) for rectal adenocarcinoma using a proteomic approach. All patients with locally-advanced rectal adenocarcinoma will be enrolled. Sequential samples of sera will be collected before, during preoperative treatment and before surgery, and analysed using a MALDI-TOF-TOF method. Proteomic analysis will be correlated to pathological response in order to identify potential early biomarkers of tumor response.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T3T4 or N+ M0 rectal carcinoma
- •histologically-proven adenocarcinoma
- •from 0 to 15 cm from the anal verge
- •patient is at least 18 years of age
- •ECOG performance status </= 2
- •Patient and doctor have signed informed consent
排除标准
- •Metastatic disease
- •T1-T2 N0 rectal carcinoma
- •Contra indication of radiotherapy or chemotherapy
- •History of cancer
- •Severe renal insufficiency
- •Symptomatic cardiac or coronary insufficiency
- •Patient included in a trial
- •Previous radiotherapy or chemotherapy for this cancer
- •No contraceptive treatment
结局指标
主要结局
differential expression of early seric biomarkers between good and bad responders.
时间窗: at inclusion and 24-48h after starting radiochemotherapy
次要结局
- modifications of isolated biomarkers within presurgical period(at inclusion, 24-48h after initiation of radiochemotherapy, at the end of radiochemotherapy (6th week) and before surgery)