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临床试验/NCT07499921
NCT07499921尚未招募不适用

Clinical and BIOgical Analyses of RECtal Tumors

Centre Leon Berard1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Blood sample collection (Procedure)

Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019

Experimental

干预措施: Tumor Samples (Procedure)

Adult patient with rectal cancer undergoing surgery at Centre Léon Bérard from 2019

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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