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临床试验/NCT02110329
NCT02110329已完成不适用

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

University Hospital, Rouen3 个研究点 分布在 1 个国家目标入组 401 人开始时间: 2010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
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

No Intervention

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)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (3)

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