Ignite Creation Date:
2024-05-06 @ 8:46 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02818231
Status:
COMPLETED
Last Update Posted:
2018-02-06
First Post:
2016-05-23
Brief Title:
Mechanisms of Cancerogenesis of Woodworkers Adenocarcinomas
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Mechanisms of Cancerogenesis for Woodworkers Adenocarcinomas Transcriptional Study of Olfactory Cleft Cells of Patients Exposed or Not to Wood Dust
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADK-FO
Brief Summary:
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
Detailed Description:
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
If inclusion is accepted patients will undergo during the nasal fiber endoscopy performed for care and under local anesthesia performed for care a brushing of the most accessible olfactory clef performed for research These samples will be compared to tumor samples which are already available REFCOR
The samples of groups 1 and 2 will be sent directly to the laboratory of Pathological Anatomy Cytology Pr-JM VIGNAUD Hospital Brabois- CHU Nancy They will briefly vortexed 5 min and frozen They will be kept in the laboratory of Pathological Anatomy Cytology Pr-JM VIGNAUD Hospital Brabois- CHU Nancy until analysis The samples will be transferred from the laboratory of Pathological Anatomy Cytology Pr-JM VIGNAUD Hospital Brabois- CHU Nancy to the Genomics Platform INSERM U954 Prof JL GUEANT- Faculty of Medicine University of Lorraine for analysis
RNA will be extracted from olfactory cells using RNeasy Mini kit Qiagen with DNase treatment The concentration and purity of the DNA RNA will be measured OD at 230nm 260nm and 280nm with a Nanodrop spectrophotometer Nyxor The RNA integrity will be determined from the profiles of ribosomal RNAs 18S 28S measured on LabOnChip 2100 Bioanalyzer System Agilent Technologies The RNA samples will be stored at -80 C until use
The transcriptome analysis will be conducted on chips Whole Human Genome 60K 8 developed by Agilent and according to the manufacturers protocol single-color Agilent protocol
At the end of the research samples will be destroyed
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
If inclusion is accepted patients will undergo during the nasal fiber endoscopy performed for care and under local anesthesia performed for care a brushing of the most accessible olfactory clef performed for research These samples will be compared to tumor samples which are already available REFCOR
The samples of groups 1 and 2 will be sent directly to the laboratory of Pathological Anatomy Cytology Pr-JM VIGNAUD Hospital Brabois- CHU Nancy They will briefly vortexed 5 min and frozen They will be kept in the laboratory of Pathological Anatomy Cytology Pr-JM VIGNAUD Hospital Brabois- CHU Nancy until analysis The samples will be transferred from the laboratory of Pathological Anatomy Cytology Pr-JM VIGNAUD Hospital Brabois- CHU Nancy to the Genomics Platform INSERM U954 Prof JL GUEANT- Faculty of Medicine University of Lorraine for analysis
RNA will be extracted from olfactory cells using RNeasy Mini kit Qiagen with DNase treatment The concentration and purity of the DNA RNA will be measured OD at 230nm 260nm and 280nm with a Nanodrop spectrophotometer Nyxor The RNA integrity will be determined from the profiles of ribosomal RNAs 18S 28S measured on LabOnChip 2100 Bioanalyzer System Agilent Technologies The RNA samples will be stored at -80 C until use
The transcriptome analysis will be conducted on chips Whole Human Genome 60K 8 developed by Agilent and according to the manufacturers protocol single-color Agilent protocol
At the end of the research samples will be destroyed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None