Continuous Observation of Smoking Subject (COSMOS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Associazione Italiana per la Ricerca sul Cancro
Information provided by (Responsible Party):
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01248806
First received: November 24, 2010
Last updated: June 17, 2014
Last verified: June 2014

November 24, 2010
June 17, 2014
October 2004
December 2014   (final data collection date for primary outcome measure)
  • To determine the prevalence of malignant pulmonary disease at the first CT examination [ Time Frame: once after enrollment ] [ Designated as safety issue: No ]
    CT scan
  • To assess the radiological detection of disease during the 10 year follow-up [ Time Frame: once per year for a 10 year follow-up period ] [ Designated as safety issue: No ]
    CT scan
Same as current
Complete list of historical versions of study NCT01248806 on ClinicalTrials.gov Archive Site
To determine the overall resectability of detected malignant tumours [ Time Frame: once after detection of malignancy ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Continuous Observation of Smoking Subject
Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population

The purpose of this study is to offer annual low-dose spiral CT radiological examination for 5 years to 5000 volunteers from the general population who are considered to be at high risk of developing lung cancer.

Lung carcinoma is one the most fatal cancer in the world. The enormous fatality rate reflects the limited chance of cure, with a dismal overall 5-year survival rate of approximately 14%. The prognosis of lung cancer depends largely on early detection and immediate treatment prior to metastatic spread. For Stage 1 lung cancer the 5-year survival rate can be as high as 70% . These data suggest that early detection and surgical treatment would have a huge beneficial effect on the lung cancer population. We developed a single arm observational study for the early detection of lung cancer with low dose CT scan in high risk asymptomatic subjects. A mainly non invasive algorithm for management of undetermined nodules was designed including low dose CT at three months for baseline nodules with diameter between 5 and 8 mm, a PET scan for nodules larger that 8 mm (not reduced after antibiotics and one month follow up CT). Lesions increasing in diameter or in density or positive nodules at CT/PET were sent to surgical biopsy (videothoracoscopic approach preferred).

Spirometry was done in all subjects prior to CT scan to evaluate correlation between BPCO and lung cancer.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum

Non-Probability Sample

community sample

Subjects at High Risk of Lung Cancer Due to Smoking
Radiation: Low dose CT scan
A low dose CT scan of the lungs is performed after the inclusion of the patient in the study and if negative for active disease, a CT scan if performed once per year for whole period of follow-up
Other Name: High resoluzione CT scan
Smokers or former smokers, Aged ≥ 50
Men and women current daily smokers or former smokers, Aged ≥ 50
Intervention: Radiation: Low dose CT scan

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5203
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 50
  • Current daily smokers or former smokers (total dose ≥ 20 pack/year, calculated by multiplying the number of packs per day by the total number of years smoked)
  • Former smoker should have stopped smoking within the 10 years before the inclusion in the study protocol

Exclusion Criteria:

  • Not currently suffering from malignant disease or having had malignant disease within the last 5 years
  • Not having known pulmonary pathology
  • Not having performed a chest CT scan during the last 2 years
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01248806
IEO S39/100
No
European Institute of Oncology
European Institute of Oncology
Associazione Italiana per la Ricerca sul Cancro
Principal Investigator: Massimo Bellomi, PhD European Institute of Oncology
European Institute of Oncology
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP