跳至主要内容
临床试验/NCT03978078
NCT03978078
招募中
不适用

Development of a Prospective Clinicobiological Database in Metastatic Digestive Cancers

Institut du Cancer de Montpellier - Val d'Aurelle1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年9月12日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Institut du Cancer de Montpellier - Val d'Aurelle
入组人数
200
试验地点
1
主要终点
Number of biological risk factors for metastatic digestive cancer

概览

简要总结

Creation of a collection of blood samples that will be collected before and then under treatment in patients with digestive adenocarcinoma during the 1st and 2nd metastatic line and which, depending on scientific progress, can be used for research projects aimed at developing tailored patient management strategies.

详细描述

Digestive cancers account for 30% of all cancers. The most common of these colorectal cancer (CRC) is the third most common cause of cancer in the world.

In the metastatic phase, patients with digestive cancers generally benefit from medical treatment based on cytotoxic chemotherapy, which can be combined with targeted therapy in certain locations. Their use is based on demonstrating a significant improvement in the overall survival of patients.

However, the therapeutic choice and follow-up of these treatments as a the first line treatment and beyond remain difficult given a cruel lack of biomarkers capable of predicting the response to these different molecules upstream but also usable during treatment to evaluate their efficacy or identify the development of secondary resistance mechanisms.

Indeed, the only biomarkers currently validated and used before the initiation of anti-cancer treatment to stratify patients are:

  • the search for mutations in Kirsten rat sarcoma viral oncogene homolog (KRAS) and neuroblastoma rat sarcoma viral oncogene (NRAS) oncogenes as predictive factors for non-response to anti-Epidermal Growth Factor receptor (EGFR) in colorectal adenocarcinomas.
  • the search for overexpression of the human epidermal growth factor (HER2) receptor to introduce trastuzumab treatment in esophageal adenocarcinomas.

In addition, they are conventionally determined from tumor tissue, which requires an invasive biopsy or surgical sampling that is difficult to repeat over time.

In this context, it seems essential to us to identify new parameters allowing a better personalization of anti-cancer treatments, by favouring blood biomarkers that have the advantage of being evaluated in a minimally invasive manner and therefore be repeated to be able to judge tumor dynamics.

To this end, we propose the creation of a collection of samples that will be collected before and then under treatment in patients with digestive adenocarcinoma in the 1st and 2nd metastatic line and which, depending on scientific progress, can be used for research projects aimed at developing tailored patient management strategies.

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 ≥ 18 years old
  • Histological documentation of adenocarcinoma of the colon or rectum, small intestine, pancreas, stomach, bile duct, oesophagus
  • Patient who will receive a first or second line metastatic chemotherapy and/or targeted therapy
  • Informed consent form (ICF) signed

排除标准

  • Male or female \< 18 years old
  • Non-adenocarcinoma histological type
  • Patient already undergoing specific treatment (chemotherapy and/or targeted therapy) in 1st or 2nd metastatic line
  • Pregnant and/or breastfeeding woman
  • Patient not affiliated to a social security system
  • Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons
  • Patient who is included in a Phase I-II therapeutic trial modifying usual management and involving additional and specific blood samples

结局指标

主要结局

Number of biological risk factors for metastatic digestive cancer

时间窗: Until the study completion : 54 months

Number of clinical risk factors for metastatic digestive cancer

时间窗: Until the study completion : 54 months

次要结局

未报告次要终点

研究者

发起方
Institut du Cancer de Montpellier - Val d'Aurelle
申办方类型
Other
责任方
Sponsor

研究点 (1)

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