Ethmoid Sinus Adenocarcinoma Clinical Trial
— ADK-FOOfficial title:
Mechanisms of Cancerogenesis for Woodworkers Adenocarcinomas: Transcriptional Study of Olfactory Cleft Cells of Patients Exposed or Not to Wood Dust
| Verified date | June 2016 |
| Source | Central Hospital, Nancy, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | March 2017 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 50 Years to 120 Years |
| Eligibility |
Inclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service ORL-CHRU NANCY | Vandoeuvre Les Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Central Hospital, Nancy, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The identification of expression profiles specific of wood dust exposure (comparison of both groups (exposed / non exposed)) | Descriptive data (Mean, Median, Min, Max). Comparison of gene expression levels ( Ttest ) of both groups: identification of expression profiles specific of each group (Ftest) | through study completion, an average of 1 year | |
| Secondary | The identification of expression profiles predictive of a nasal adenocarcinoma transformation. | Comparison of gene expression levels of the 15 exposed patients with known gene expression levels of 15 tumor samples (intestinal adenocarcinomas related to wood dust) (T Test) Identification of common modifications of gene expression (Ftest) | through study completion, an average of 1 year | |
| Secondary | The acceptability of the brushing technique | The acceptability will be evaluated on a composite criterion with three sub-criteria subjective representation of the utility of the screening (mean >5/10) subjective evaluation of the acceptability (pain, discomfort, complication) (mean>5/10) agreement for an eventual second sample (>90%) All sub-criteria must be fulfilled to meet this outcome |
through study completion, an average of 1 year |