Subjects at High Risk of Lung Cancer Due to SmokingCOSMOSNCT01248806
Continuous Observation of Smoking Subject
An observational study of Subjects at High Risk of Lung Cancer Due to Smoking, run by European Institute of Oncology at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Subjects at High Risk of Lung Cancer Due to Smoking
- What is being tested?
- Low dose CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 5,203 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2004to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community sample
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Low dose CT scan
- Keywords
- Lung nodule, Screening, Spiral low - dose computed tomography, Lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose CT scanRadiation
Also called High resoluzione 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
| Study group | Role | What they receive |
|---|---|---|
| Smokers or former smokers, Aged ≥ 50 | Men and women current daily smokers or former smokers, Aged ≥ 50 Receives: Radiation: Low dose CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence of malignant pulmonary disease at the first CT examination
CT scan
Measured: once after enrollment
To assess the radiological detection of disease during the 10 year follow-up
CT scan
Measured: once per year for a 10 year follow-up period
Secondary outcomes (1)
To determine the overall resectability of detected malignant tumours
Measured: once after detection of malignancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startOct 2004
- Primary completionJan 2017
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subjects at High Risk of Lung Cancer Due to SmokingStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Responsible party
- Sponsor
- Investigators
- Massimo Bellomi, PhD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248806
- Sponsor's protocol ID
- IEO S39/100
- Acronym
- COSMOS
- Status last verified
- May 2022
- First submitted
- 24 Nov 2010
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Veronesi G, Bellomi M, Mulshine JL, Pelosi G, Scanagatta P, Paganelli G, Maisonneuve P, Preda L, Leo F, Bertolotti R, Solli P, Spaggiari L. Lung cancer screening with low-dose computed tomography: a non-invasive diagnostic protocol for baseline lung nodules. Lung Cancer. 2008 Sep;61(3):340-9. doi: 10.1016/j.lungcan.2008.01.001. Epub 2008 Mar 4.
PubMed 18308420Pelosi G, Sonzogni A, Veronesi G, De Camilli E, Maisonneuve P, Spaggiari L, Manzotti M, Masullo M, Taliento G, Fumagalli C, Bellomi M, Travis WD, Kadivar M, Viale G. Pathologic and molecular features of screening low-dose computed tomography (LDCT)-detected lung cancer: a baseline and 2-year repeat study. Lung Cancer. 2008 Nov;62(2):202-14. doi: 10.1016/j.lungcan.2008.03.012. Epub 2008 May 2.
PubMed 18450320Veronesi G, Bellomi M, Veronesi U, Paganelli G, Maisonneuve P, Scanagatta P, Leo F, Pelosi G, Travaini L, Rampinelli C, Trifiro G, Sonzogni A, Spaggiari L. Role of positron emission tomography scanning in the management of lung nodules detected at baseline computed tomography screening. Ann Thorac Surg. 2007 Sep;84(3):959-65; discussion 965-6. doi: 10.1016/j.athoracsur.2007.04.058.
PubMed 17720408
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population
- ClinicalTrials.gov ID
- NCT01248806
- Acronym / sponsor ID
- COSMOS / IEO S39/100
- Keywords
- Lung nodule, Screening, Spiral low - dose computed tomography, Lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,203 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Study start
- Oct 2004 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smokers or former smokers, Aged ≥ 50 | – | Radiation: Low dose CT scanMen and women current daily smokers or former smokers, Aged ≥ 50 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose CT scanAlso: High resoluzione CT scanA 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 | Radiation | Smokers or former smokers, Aged ≥ 50 |
Primary outcome
To determine the prevalence of malignant pulmonary disease at the first CT examination
Time frame: once after enrollment
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
CT scan
1 secondary outcome
To determine the overall resectability of detected malignant tumours
Time frame: once after detection of malignancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Results publication: PubMed 18308420Veronesi G, Bellomi M, Mulshine JL, Pelosi G, Scanagatta P, Paganelli G, Maisonneuve P, Preda L, Leo F, Bertolotti R, Solli P, Spaggiari L. Lung cancer screening with low-dose computed tomography: a non-invasive diagnostic protocol for baseline lung nodules. Lung Cancer. 2008 Sep;61(3):340-9. doi: 10.1016/j.lungcan.2008.01.001. Epub 2008 Mar 4.
- Results publication: PubMed 18450320Pelosi G, Sonzogni A, Veronesi G, De Camilli E, Maisonneuve P, Spaggiari L, Manzotti M, Masullo M, Taliento G, Fumagalli C, Bellomi M, Travis WD, Kadivar M, Viale G. Pathologic and molecular features of screening low-dose computed tomography (LDCT)-detected lung cancer: a baseline and 2-year repeat study. Lung Cancer. 2008 Nov;62(2):202-14. doi: 10.1016/j.lungcan.2008.03.012. Epub 2008 May 2.
- Results publication: PubMed 17720408Veronesi G, Bellomi M, Veronesi U, Paganelli G, Maisonneuve P, Scanagatta P, Leo F, Pelosi G, Travaini L, Rampinelli C, Trifiro G, Sonzogni A, Spaggiari L. Role of positron emission tomography scanning in the management of lung nodules detected at baseline computed tomography screening. Ann Thorac Surg. 2007 Sep;84(3):959-65; discussion 965-6. doi: 10.1016/j.athoracsur.2007.04.058.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Bellomi, PhD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjects at High Risk of Lung Cancer Due to Smoking, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence of malignant pulmonary disease at the first CT examination (time frame: once after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01248806, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.