Clinical and BIOgical Analyses of RECtal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Establish a correlation between biological data and clinical data of patients with rectal tumors
研究概览
简要总结
Rectal cancer is a common cancer with an incidence of approximately 14,000 new cases per year in France. The survival rate is approximately 50% at 5 years, ranging from 90% for patients with localized rectal cancer to 18% for patients with metastases.
Surgery with local or complete exicion is the standard treatment for early stages. The implementation of Total Neoadjuvant Therapy (TNT) for locally advanced stages has led to a significant improvement in the prognosis for rectal cancer. The complete pathological response rate of aproximately 20% after TNT has led to the "Watch and Wait" strategy, which aims to avoid surgery and preserve the rectum, but there is currently no reliable method for identifying responders. Rectal tumors with mismatch repair defiency (MMRd) and/or High microsatellite instability (MSI-H) are considered resistant to neoadjuvant chemotherapy, but those patients can benefit from immunotherapy treatment. Identifying patients who will respond to immunotherapy is crucial for this type of treatment. Pre-existing immune infiltration within the tumor microenvironnement prior to any treatment is an important prognostic factor and could help predict response to immunotherapy, as well as neoadjuvant treatment. Studying the immune microenvironnement and how it changes during different treatments could therefore help identify responders for whom treatment without surgery could be considered in order to avoid the deterioration in quality of life often associated with this procedure in this type of cancer. Finally, analysis of residual tumor cells after chemotherapy and/or chemoradiotherapy could help identify possible mechanisms of resistance to current treatments and develop strategies to counter them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 or over
- •Patients who have undergone surgery for rectal cancer since January 1st, 2019
- •Histological diagnosis of rectal adenocarcinoma confirmed on a surgical sample
排除标准
- •Not applicable
研究组 & 干预措施
Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019
干预措施: Blood sample collection (Procedure)
Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019
干预措施: Tumor Samples (Procedure)
Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019
干预措施: Healthy tissue sample (Procedure)
结局指标
主要结局
Establish a correlation between biological data and clinical data of patients with rectal tumors
时间窗: Until up to 3 years follow-up of the last patient enrolled
次要结局
- Comparison of stroma of tumor samples from : 1) primary tumors operated after preoperative chemotherapy, 2) biopsies performed before chemotherapy and 3) primary tumors operated without preoperative treatment(Until up to 3 years follow-up of the last patient enrolled)
- Comparision of healthy tissue, stroma of primary tumors samples and metastases in patients for whom samples of primary tumor and metastases will be available.(Until up to 3 years follow-up of the last patient enrolled)
