Simultaneous Detection of Somatic Quantitative Molecular Alterations Using the Qantitative Multiplex Pcr of Short Fluorescent Fragments Method (QMPSF) in Stage II-III Colon Cancer: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 401
- 试验地点
- 3
- 主要终点
- Recurence rate according to molecular results
研究概览
简要总结
Lymph node involvement remains the main criteria for postoperative chemotherapy in patients with colon cancer (CC) without distant metastasis. To date, the prognostic value of the somatic quantitative molecular alterations such as loss or gain of genomic region is not established in CC.
AIMS & METHODS: Using the one-step screening method based on the Quantitative Multiplex PCR of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the simultaneous detection of main quantitative somatic alterations in stage II-III CC.
Patients and Methods. We enrolled and collected all baseline characteristics of patients operated for a stage II-III CC with storage frozen tissues. The QMPSF was based on a simultaneous amplification of 9 selected target genomic sequences from literature: DCC (18q21); EGFR (7p12); P53 (17p13.1); BLK (8p23-p22); c-myc (8q24.12); APC (5q22.2); ERBB2 (17q12); STK6 (20q13.31); NR21 (14p11.1) and two control: DCOHM (5q31.1); HMBS (11q23.3). Comparison of each amplicon electropherograms obtained from tumour vs normal peritumoral tissue allowed us to identified gain or loss genomic region. The primary end-point was the local and/or distant recurrence and relation between clinical and single or combined molecular alterations and recurrence were evaluated.
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
- •age over 18
- •localized colon cancer
- •proven adenocarcinoma
- •surgery R0
- •no metastatic disease
- •stage II or III
- •WHO performance status 0, 1 or 2
- •availaible frozen tissue
- •written consent
- •no major co-morbidities
排除标准
- •metastatic disease
- •hereditary colorectal cancer
- •rectal cancer
研究组 & 干预措施
stage II-III colon cancer treated with surgery
stage II-III colon cancer treated with surgery
干预措施: evaluation of the recurrence rate according to molecular analysis (Genetic)
结局指标
主要结局
Recurence rate according to molecular results
时间窗: 36 months
Using the one-step screening method based on the Quantitative Multiplex PCR of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the simultaneous detection of main quantitative somatic alterations in stage II-III CC.
次要结局
- Survival rate according to molecular results(60 months)
