跳至主要内容
临床试验/NCT01636544
NCT01636544已完成不适用

Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity

Institut Pasteur2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Detection of others infectious agents

研究概览

简要总结

Recent studies estimated that 15 to 20% of all cancers in humans are associated with viruses. Among oral cancer about 90% are oral squamous cell carcinomas (OSCC). Alcohol and tobacco consumption have been recognized for years as the main risk factors for development of OSCCs. However, 10 to 20% of patients suffering from OSCCs are non-smokers and/ or non-drinkers. Consequently, the hypothesis of another agent responsible has risen. Indeed, several studies have suggested the possibility that a virus could be associated with or be a causal agent of OSCC. The first objective is to detect and characterize the presence of infectious agent (mostly virus) transcripts in pre-malignant or malignant tumours from patients with OSCCs.The secondary objectives are (i) to associate and (ii) if possible define a causality link between these agents and a subset of potentially malignant disorders and/or OSCCs.

研究设计

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

  • Patient over 18 years,
  • For subgroup "potentially malignant disorder : clinical diagnosis of leukoplakia,
  • For subgroup "OSCC" : histological diagnosis of OSCC,
  • Patient who never smoked, or light smoker, (≤5 pack-year) or 15 years of cessation,
  • Patient who never drank, or light drinker (≤ 20 g/day for men and 10g/day for women) or 15 years of cessation,
  • Informed consent signed.

排除标准

  • Previous treatment of oral cancer,

结局指标

主要结局

Detection of others infectious agents

时间窗: 30 months

(i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)

Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method.

时间窗: 30 months

qPCR method

次要结局

  • Clonality of viral agent(30 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验