Ethmoid Sinus AdenocarcinomaADK-FONCT02818231
Mechanisms of Cancerogenesis of Woodworkers Adenocarcinomas
An observational study of Ethmoid Sinus Adenocarcinoma, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 120 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ethmoid Sinus Adenocarcinoma
- What is being tested?
- Brushing of the olfactory cleft
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Mar 2017
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 120 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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-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.
- Conditions
- Ethmoid Sinus Adenocarcinoma
- Being tested
- Brushing of the olfactory cleft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brushing of the olfactory cleftOther
Non invasive sampling of olfactory cleft cells, by brushing under local anesthesia during fiberendoscopy Form: survey of acceptability
| Study group | Role | What they receive |
|---|---|---|
| NON EXPOSED | Male, >50 years, unexposed to wood dust, without any nasal pathology, without known tumor
-> Brushing of the olfactory cleft Receives: Other: Brushing of the olfactory cleft | |
| EXPOSED | Male, >50 years, exposed to wood dust, without any nasal pathology, without known tumor
-> Brushing of the olfactory cleft Receives: Other: Brushing of the olfactory cleft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
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)
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ethmoid Sinus AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice Gallet, MD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818231
- Sponsor's protocol ID
- 2015-A02004-45
- Acronym
- ADK-FO
- Status last verified
- Jun 2016
- First submitted
- 23 May 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Cancerogenesis for Woodworkers Adenocarcinomas: Transcriptional Study of Olfactory Cleft Cells of Patients Exposed or Not to Wood Dust
- ClinicalTrials.gov ID
- NCT02818231
- Acronym / sponsor ID
- ADK-FO / 2015-A02004-45
- Conditions
- Ethmoid Sinus Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NON EXPOSED | – | Other: Brushing of the olfactory cleftMale, >50 years, unexposed to wood dust, without any nasal pathology, without known tumor -> Brushing of the olfactory cleft |
| EXPOSED | – | Other: Brushing of the olfactory cleftMale, >50 years, exposed to wood dust, without any nasal pathology, without known tumor -> Brushing of the olfactory cleft |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- Male, > 50 years
- No known tumor
- patient needing fiberendoscopy, but for nasal pathology
- informed consent given
- affiliation to a healthcare scheme compulsory
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brushing of the olfactory cleftNon invasive sampling of olfactory cleft cells, by brushing under local anesthesia during fiberendoscopy Form: survey of acceptability | Other | EXPOSED, NON EXPOSED |
Primary outcome
The identification of expression profiles specific of wood dust exposure (comparison of both groups (exposed / non exposed))
Time frame: 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)
2 secondary outcomes
The identification of expression profiles predictive of a nasal adenocarcinoma transformation.
Time frame: through study completion, an average of 1 year
The acceptability of the brushing technique
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Gallet, MD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ethmoid Sinus Adenocarcinoma, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The identification of expression profiles specific of wood dust exposure (comparison of both groups (exposed / non exposed)) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.