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OpenTrials
Completed

NCT Number: NCT01248806

Continuous Observation of Smoking Subject

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

European Institute of Oncology

Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose CT scan

Radiation

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 names: High resoluzione CT scan

Primary outcomes

  1. To determine the prevalence of malignant pulmonary disease at the first CT examination

    Time frame: once after enrollment

    CT scan

  2. 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

    CT scan

Secondary outcomes

  1. To determine the overall resectability of detected malignant tumours

    Time frame: once after detection of malignancy

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Collaborators

  • Associazione Italiana per la Ricerca sul Cancro

Registry information

Official study title

Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population

Acronym: COSMOS

Important dates

Study start
2004
Primary completion
2017
Study completion
2021
First posted
Nov 25, 2010
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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