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临床试验/NCT03265496
NCT03265496终止不适用

Correlation Between Tissue and Plasmatic EGFR in CBNPC With EGFR Mutation or Predictive Factor of EGFR Mutation

Centre Oscar Lambret2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年7月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
21
试验地点
2
主要终点
Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. NGS.

研究概览

简要总结

Condorde main objective is to evaluate the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed on ctDNA after liquid biopsy. EGFR status will be assessed by real time PCR (rtPCR), digital PCR (dPCR) and Next Generation Sequencing (NGS) in patients with chemotherapy naive lung carcinoma.

详细描述

Newest therapeutic breakthrough are often based on molecular analysis of tumoral tissue before treatment initiation or after emergence of resistance. Tumoral tissue is commonly obtained by biopsy. However, tumor biopsy is an invasive, scarcely repeatable and costly technics. Moreover, tumor samples, obtained by biopsy, doesn't represent tumor heterogeneity and cannot inform about tumor evolution over time.

Recent improvement have been done in detection and characterization of blood circulating tumoral DNA (ctDNA). ctDNA reach regularly the blood stream after tumoral cell apoptosis or necrosis and could be extract and sequenced by some molecular biology technics such as real time PCR (rtPCR), digital PCR (dPCR) or next generation sequencing (NGS). Interesting, Several studies demonstrate that some genomic alterations of solid cancer can be characterized after sequencing of ctDNA. Other experiments pointed that ctDNA level could be linked to tumor stage and patient prognostic.

These progress lead to the development of a new non invasive method for extraction of ctDNA called liquid biopsy (LB). LB could be useful for monitor tumoral genotype, assess tumor response to treatment and detect residual tumor cells after curative treatment. Moreover LB could be an essential method for study of tumor cells molecular alterations mechanisms during targeted cancer therapies, when clinical resistance occurs.

Non-small cell lung cancer (NSCLC) is the most frequently diagnosticated type of lung cancer. Regular first line chemotherapy is based on the use of platinum salts. However, some mutations in the EGFR gene could add sensitivity of NSCLC to tyrosine kinase inhibitors such as gefitinib, erlotinib or afatinib. Consequently, the search for molecular mutations in genome of NSCLC cells is of prior interest for patients with clinically advanced NSCLC.

Recently, some studies demonstrate that mutational EGFR status of NSCLC was sharply correlated between tumoral tissue, obtained by classical biopsy, and ctDNA, collected by liquid biopsy.

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

  • At least 18 years
  • Metastatic lung carcinoma
  • With: - EGFR gene mutation
  • Or at least 2 predictive factors of addictive mutation (Women, non smocking or cessation > 3 years, Asiatic, lung adenocarcinoma)
  • Eligible for 1st line treatment
  • Performance status ≤ 3
  • Available tumor sample or tumor reachable for biopsy
  • With informed and signed consent
  • Affiliation to the National Social Security System

排除标准

  • Previous radiotherapy treatment in months preceding initials samples
  • Pregnant or breastfeeding women
  • Patient not able to give consent or unwilling to provide consent

研究组 & 干预措施

study procedure

Experimental

Clinical exam. Liquid biopsy. Diagnostic exam (biopsy and imagery). 1st line treatment. tumor evaluation. Biopsy

干预措施: Clinical exam (Procedure)

study procedure

Experimental

Clinical exam. Liquid biopsy. Diagnostic exam (biopsy and imagery). 1st line treatment. tumor evaluation. Biopsy

干预措施: Liquid biopsy (Procedure)

study procedure

Experimental

Clinical exam. Liquid biopsy. Diagnostic exam (biopsy and imagery). 1st line treatment. tumor evaluation. Biopsy

干预措施: Diagnostic exam (Procedure)

study procedure

Experimental

Clinical exam. Liquid biopsy. Diagnostic exam (biopsy and imagery). 1st line treatment. tumor evaluation. Biopsy

干预措施: 1st line treatment (Drug)

study procedure

Experimental

Clinical exam. Liquid biopsy. Diagnostic exam (biopsy and imagery). 1st line treatment. tumor evaluation. Biopsy

干预措施: tumor evaluation (Procedure)

study procedure

Experimental

Clinical exam. Liquid biopsy. Diagnostic exam (biopsy and imagery). 1st line treatment. tumor evaluation. Biopsy

干预措施: Biopsy (Biological)

结局指标

主要结局

Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. NGS.

时间窗: Baseline

For patient with mutant EGFR. Evaluate, by next generation sequencing at diagnostic, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy.

次要结局

  • Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. rtPCR.(Baseline)
  • Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. rtPCR.(From Baseline to disease progression, up to 2 years)
  • Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. dPCR.(Baseline)
  • Incidence of oncogenic mutation for patients with predictive factors(From Baseline to disease progression, up to 2 years)
  • Predictive value of ctDNA during treatment with EGFR targeting therapy.(From Baseline to disease progression, up to 2 years)
  • Mutations on ctDNA and tumor biopsy.(From Baseline to disease progression, up to 2 years)
  • Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. NGS.(From Baseline to disease progression, up to 2 years)
  • Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. dPCR.(From Baseline to disease progression, up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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