Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure (AMORCE-CBP)
Interest of Morphometric Analysis of Sputum Cytology for Lung Cancer Screening in Workers Highly Exposed to Asbestos - Exploratory Analysis of Biomarkers Predictive for Lung Cancer
Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this population relies on repeated CT-scans which are more accurate for detection of peripheral lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using automate cytometry may be of interest in this population, alone or in combination with CT-scan.
An ancillary study will evaluate the interest of blood predictive biomarkers.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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-
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Caen, France, 14000
- CAEN University Hospital
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Le Havre, France, 76600
- Le Havre Hospital
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Rouen, France, 76031
- Rouen University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- High professional asbestos exposure
- Member of a former cohort recruited between 2000 and 2006 in Caen, Rouen and Le Havre (inclusion criteria: 50-75 years at the time of initial recruitment, high intermittent asbestos exposure >= 1 year, or high discontinuous asbestos exposure >=10 years). All the living members of the cohort will be contacted: a maximum of 1000 subjects is expected, probably less.
- Informed consent signed
Exclusion Criteria:
- Personal history of lung cancer
- Refusal of the study protocol
- Uncontrolled asthma or lung failure
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: Screening
Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.
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All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Risk of false positive
Délai: within 3 months
|
Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum
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within 3 months
|
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detection of lung cancer
Délai: within 3 months
|
Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum
|
within 3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Sensitivity for lung cancer detection compared with CT-scan
Délai: within 3 months
|
Ratio of sensitivity (RSN) for lung cancer detection in reference with CT scan. Interest of the combination "cytometry + CT-scan" compared with CT-scan alone will also be evaluated. |
within 3 months
|
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Specificity for detection of lung cancer
Délai: within 3 months
|
Ratio of false positives (RFP) of automated cytometry analysis compared with CT-scan screening. The combination "automated cytometry + CTscan" will also be evaluated compared with CT scan alone. |
within 3 months
|
|
Predictive Biomarkers
Délai: Annually during a maximum of 5 years
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Frequency of specific biomarkers at the time of screening.
Links between lung cancer during 5 years of prospective follow-up.
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Annually during a maximum of 5 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Lydia GUITTET, MD,PhD, Caen University Hospital, INSERM
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2011-A01380-41
- PHRC11-221 (Autre subvention/numéro de financement: French Ministry of Health (DGOS))
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