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
  Purpose

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.


Condition Intervention
Subjects at High Risk of Lung Cancer Due to Smoking
Radiation: Low dose CT scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population

Resource links provided by NLM:


Further study details as provided by European Institute of Oncology:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • To determine the overall resectability of detected malignant tumours [ Time Frame: once after detection of malignancy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum


Enrollment: 5203
Study Start Date: October 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Smokers or former smokers, Aged ≥ 50
Men and women current daily smokers or former smokers, Aged ≥ 50
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248806

Locations
Italy
European Institute of Oncology
Milan, Italy
Sponsors and Collaborators
European Institute of Oncology
Associazione Italiana per la Ricerca sul Cancro
Investigators
Principal Investigator: Massimo Bellomi, PhD European Institute of Oncology
  More Information

Publications:
Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT01248806     History of Changes
Other Study ID Numbers: IEO S39/100
Study First Received: November 24, 2010
Last Updated: June 17, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by European Institute of Oncology:
Lung nodule
Screening
Spiral low - dose computed tomography
Lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014