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Mechanisms of Cancerogenesis of Woodworkers Adenocarcinomas (ADK-FO)

5 februari 2018 uppdaterad av: Central Hospital, Nancy, France

Mechanisms of Cancerogenesis for Woodworkers Adenocarcinomas: Transcriptional Study of Olfactory Cleft Cells of Patients Exposed or Not to Wood Dust

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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-J.M. 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-J.M. VIGNAUD Hospital Brabois- CHU Nancy) until analysis. The samples will be transferred from the laboratory of Pathological Anatomy Cytology (Pr-J.M. 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 manufacturer's protocol (single-color Agilent protocol).

At the end of the research samples will be destroyed.

Studietyp

Observationell

Inskrivning (Faktisk)

28

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Vandoeuvre Les Nancy, Frankrike, 54511
        • Service ORL-CHRU NANCY

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år till 120 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Manlig

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Consultation requiring fiberendoscopy, planned in the ENT department of the CHRU of Nancy, in a context of routine care or of monitoring of professionnal wood dust exposure

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
NON EXPOSED

Male, >50 years, unexposed to wood dust, without any nasal pathology, without known tumor

-> Brushing of the olfactory cleft
Övrig: Brushing of the olfactory cleft
Non invasive sampling of olfactory cleft cells, by brushing under local anesthesia during fiberendoscopy Form: survey of acceptability
EXPOSED

Male, >50 years, exposed to wood dust, without any nasal pathology, without known tumor

-> Brushing of the olfactory cleft
Övrig: Brushing of the olfactory cleft
Non invasive sampling of olfactory cleft cells, by brushing under local anesthesia during fiberendoscopy Form: survey of acceptability

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The identification of expression profiles specific of wood dust exposure (comparison of both groups (exposed / non exposed))
Tidsram: 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)
through study completion, an average of 1 year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The identification of expression profiles predictive of a nasal adenocarcinoma transformation.
Tidsram: through study completion, an average of 1 year
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
The acceptability of the brushing technique
Tidsram: through study completion, an average of 1 year

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Central Hospital, Nancy, France

Utredare

  • Huvudutredare: Patrice Gallet, MD, CHRU NANCY

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2016

Primärt slutförande (Faktisk)

1 september 2016

Avslutad studie (Faktisk)

1 mars 2017

Studieregistreringsdatum

Först inskickad

23 maj 2016

Först inskickad som uppfyllde QC-kriterierna

27 juni 2016

Första postat (Uppskatta)

29 juni 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 februari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 februari 2018

Senast verifierad

1 juni 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2015-A02004-45

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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