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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01687647
Other study ID # 2011-A01380-41
Secondary ID PHRC11-221
Status Enrolling by invitation
Phase Phase 3
First received August 31, 2012
Last updated April 8, 2014
Start date September 2012
Est. completion date December 2019

Study information

Verified date April 2014
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date December 2019
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 56 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Other:
low-dose CT-scan AND induced sputum sample AND blood test
All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum

Locations

Country Name City State
France Caen University Hospital Caen
France Le Havre Hospital Le Havre
France Rouen University Hospital Rouen

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Caen Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Risk of false positive Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum within 3 months Yes
Primary detection of lung cancer Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum within 3 months No
Secondary Sensitivity for lung cancer detection compared with CT-scan 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 No
Secondary Specificity for detection of lung cancer 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 Yes
Secondary Predictive Biomarkers 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 No
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