跳至主要内容
临床试验/NCT02813928
NCT02813928已完成不适用

Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment

University Hospital, Limoges37 个研究点 分布在 1 个国家目标入组 473 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
473
试验地点
37
主要终点
The presence of recurrences detected for patients curatively treated for a CRC stages II and III within the 3 years of follow-up.

研究概览

简要总结

Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses is based on surgical resection, when possible, chemotherapy and targeted therapies. To detect recurrences or metastases, a surveillance strategy is recommended for patients able to withstand complementary treatment during a five-year period. Over this period, the probability of one false-positive result is 87%. Considering that less than 10% of recurrent patients are suitable for potentially curative treatment and that more intensive programs enable an increase of the overall rate of curative resection but do not result in reduced mortality, less time and cost-consuming, tailored follow-up is necessary. The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance.

Tubes for ccfDNA analysis will be taken during medical examination at the same time of the CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent for analysis in the laboratory INSERM (National Health Institute) of Montpellier and the remaining plasma will be kept in biological collection.

Patients will have a consultation of follow-up every 3-4 months during which the dosage of CEA and ccfDNA will be realized as well as a medical examination, a general examination (weight, size, and blood pressure), an evaluation of the indices of performance status and a nutritional evaluation in case of loss of weight.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Age ≥ 18 years
  • Primary diagnosis of stages II and III CRC:
  • is already operated and histological proven (biopsy at least)
  • is patient that must be operated: curative treatment for stages II and III CRC
  • Patient benefiting from a program personalized by care
  • Written informed consent

排除标准

  • Patient already treated for stages II and III CRC and in surveillance
  • Patient with indication or with palliative treatment
  • Pregnant or nursing patients
  • Known pregnancy
  • Difficulties to understand the protocol
  • Patients under protection measure (guardianship, curatorship, protection of justice)

结局指标

主要结局

The presence of recurrences detected for patients curatively treated for a CRC stages II and III within the 3 years of follow-up.

时间窗: 3 years

次要结局

未报告次要终点

研究者

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

研究点 (37)

Loading locations...

相似试验