Mechanisms of Cancerogenesis for Woodworkers Adenocarcinomas: Transcriptional Study of Olfactory Cleft Cells of Patients Exposed or Not to Wood Dust
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The identification of expression profiles specific of wood dust exposure (comparison of both groups (exposed / non exposed))
研究概览
简要总结
Nasal adenocarcinomas are closely related to wood dust exposure. The precise mechanisms of carcinogenesis leading to the transformation of the respiratory mucosa into a colonic-like mucosa remain unknown: chronic exposure to wood dust may cause chronic inflammation that may lead to pre-degenerative lesions, hypothesis yet unconfirmed. The tumor development requires the activation of a particular gene: CDX2. The working hypothesis is that chronic wood dust exposure is responsible for changes in genes of inflammation, which can in turn lead to changes in the expression of CDX2 and its cofactors, thus making possible the genesis of adenocarcinoma. This work is a pilot study aiming to better understand the mechanisms of carcinogenesis, and to study the feasibility of a larger prospective screening for woodworkers adenocarcinomas. Cells will be obtained from the at risk area (olfactory cleft) by a noninvasive method (brushing) in healthy volunteers (unexposed to wood dust) and in exposed volunteers to compare their genomes and study the genomic changes related to wood dust exposure.
详细描述
Pilot study, single center, prospective and retrospective, aiming to better understand the mechanisms of carcinogenesis of nasal adenocarcinoma among 2 groups of subjects based on their potential risk of nasal adenocarcinoma.
Patients will be recruited prospectively, in the ENT department (Prof. R. JANKOWSKI-Institut Lorrain Heart and vessels Louis Mathieu -Hospitals Brabois-CHU Nancy), during a visit for another medical reason.
They will be divided into 2 groups as follows:
- Group 1: NON EXPOSED : control group: patients not exposed to wood dust (low risk)
- Group 2: EXPOSED: patients exposed to wood dust (high risk)
After complete information, inclusion in the study will be proposed to patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, > 50 years
- •No known tumor
- •patient needing fiberendoscopy, but for nasal pathology
- •informed consent given
- •affiliation to a healthcare scheme compulsory
- •prior medical exam 'NON EXPOSED' group: no wood dust exposure 'EXPOSED' group : wood dust exposure > 20 years with delay since the beginning of exposure > 30 years
- •Exclusion criteria:
- •Prior radiotherapy on sinus or nasal fossa
- •Inflammatory disease of nasal fossa
- •Genetic disease with cancer risk (xeroderma pigmentosum, chromosomal abnormality deletion or translocation, DNA repair deficiency)
- •No informed consent
- •No affiliation to a healthcare scheme compulsory
- •prior medical exam
- •Contra-indication to Xylocaine
排除标准
- 未提供
结局指标
主要结局
The identification of expression profiles specific of wood dust exposure (comparison of both groups (exposed / non exposed))
时间窗: through study completion, an average of 1 year
Descriptive data (Mean, Median, Min, Max). Comparison of gene expression levels ( Ttest ) of both groups: identification of expression profiles specific of each group (Ftest)
次要结局
- The identification of expression profiles predictive of a nasal adenocarcinoma transformation.(through study completion, an average of 1 year)
- The acceptability of the brushing technique(through study completion, an average of 1 year)