Influence of the Surgical Technique Used for Colectomies on the Concentration of Circulating Tumor DNA and the Presence of Circulating Tumor Cells: Comparison of the "no Touch" Technic With Either First Clamping of the Mesenteric Vessels or First Mobilization of the Tumor Followed by Clamping.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Presence of ctDNA
研究概览
简要总结
Colectomy is the most commonly used therapeutic approach for the treatment of non-metastatic colorectal cancer. This approach is generally very effective however the rate of recurrence and the appearance of metachronous metastasis remains a major problem in the postoperative period. One of the hypothesis that can explain this tumor progression is the dissemination of tumor cells at the time of tumor mobilization. In this work, we wish to verify this hypothesis by comparing two surgical technics used in our department for left or right colectomies: respectively either first section of the mesenteric vessels followed by the mobilization of the tumor or first mobilization of the tumor followed by the section of the mesenteric vessels. To evaluate the dissemination, we will study two disseminations markers that have shown their prognostic value: i) circulating tumor cells (which represent a direct marker of dissemination) and ii) tumor circulating DNA (which is an indirect marker) but has the advantage of being more representative of all tumor clones and therefore the tumor burden released into the blood at the time of surgery).
详细描述
A / Epidemiology of colorectal cancer
Colorectal cancer remains the third most common cancer in France in 2017 with an incidence of about 44,000 new cases in 2017 and nearly 18,000 deaths each year. The ColoRectal Cancer (CRC) ranks second among cancer deaths behind lung cancer and breast cancer. Thanks to diagnostic and therapeutic progress, the mortality rate decrease of 1.5% in men and 1.1% in women between 2005 and 2012.
Despite these numbers, colorectal cancer has a good prognosis when diagnosed at an early stage. In fact, the 5-year relative survival is 91% for localized stages (stage I and II) and 70% for stages with locoregional and lymph nodes invasion (stage III). On the other hand, about 25% of the patients at the time of diagnosis have metastasis (stage IV), with a survival at 5 years of 11%. Those data explain that the mortality of this cancer is mainly due to the spread of the primary tumor to secondary locations, mainly liver or lung.
The unstable microsatellite phenotype (ISM) is an important colonic carcinogenesis pathway, find in approximately 15% of operable colorectal cancers (CRC) and may be of sporadic or hereditary origin. Several studies have shown that patients with MSI tumors have a better prognosis than patients with stable microsatellite tumors (SSM) due to a better response to platinum-based chemotherapy. The determination of this status therefore determines the adjuvant treatment of CRC and is determined in anatomopathology on the analysis of the operative specimen.
B / The place of surgery in the care of the CCR:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women, aged over18 years old and more
- •colectomy for localized colon adenocarcinoma
- •Adenocarcinoma of the colon stage 1,2,3
- •Patient having signed the consent
排除标准
- •carcinomatosis
- •metastatic tumor
- •pregnancy and breast feeding
结局指标
主要结局
Presence of ctDNA
时间窗: Day 3
Evaluate the presence of ctDNA on D3 postoperatively by comparing the two methods of surgery: "no touch" method and first mobilization of the tumor in patients with colon cancer
次要结局
- MSI status(Day -1, Day 1 and Day 3)
- Presence of CTC(Day -1, Day 1 and Day 3)