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Mechanisms of Cancerogenesis of Woodworkers Adenocarcinomas (ADK-FO)

5. februar 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

28

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
NON EXPOSED

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

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The identification of expression profiles specific of wood dust exposure (comparison of both groups (exposed / non exposed))
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The identification of expression profiles predictive of a nasal adenocarcinoma transformation.
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Central Hospital, Nancy, France

Efterforskere

  • Ledende efterforsker: Patrice Gallet, MD, Chru Nancy

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2016

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

23. maj 2016

Først indsendt, der opfyldte QC-kriterier

27. juni 2016

Først opslået (Skøn)

29. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. februar 2018

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2015-A02004-45

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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