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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Caen, Frankrig, 14000
- Caen University hospital
-
Le Havre, Frankrig, 76600
- Le Havre Hospital
-
Rouen, Frankrig, 76031
- Rouen University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Screening
Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.
|
All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk of false positive
Tidsramme: within 3 months
|
Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum
|
within 3 months
|
|
detection of lung cancer
Tidsramme: within 3 months
|
Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum
|
within 3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity for lung cancer detection compared with CT-scan
Tidsramme: 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
|
|
Specificity for detection of lung cancer
Tidsramme: 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
Tidsramme: Annually during a maximum of 5 years
|
Frequency of specific biomarkers at the time of screening.
Links between lung cancer during 5 years of prospective follow-up.
|
Annually during a maximum of 5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Lydia GUITTET, MD,PhD, Caen University Hospital, INSERM
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011-A01380-41
- PHRC11-221 (Andet bevillings-/finansieringsnummer: French Ministry of Health (DGOS))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .