Lung CancerNCT00188734
Early Lung Cancer Detection Using Computed Tomography
An observational study of Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Early detection of lung cancer may improve treatment outcomes. Risk factors have been identified, suggesting a population which might benefit from regular screening. Lung cancer screening using low-dose computed tomography (LDCT) has experienced a recent renaissance with reported sensitivity for detection of lung… Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- 5,000 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2003to Jun 2016
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: high risk current and former smokers
Who may be able to join
- 55 years or older at least 10 pack-year history of smoking general good health
Who cannot join
- any prior cancers except non-melanotic skin cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Cancer Screening in High-risk Smokers Using Low-dose Computed Tomography
Early detection of lung cancer may improve treatment outcomes. Risk factors have been identified, suggesting a population which might benefit from regular screening. Lung cancer screening using low-dose computed tomography (LDCT) has experienced a recent renaissance with reported sensitivity for detection of lung cancer of 2.7% in high-risk populations. The purpose of this study is to evaluate the utility of LCDT for the early diagnosis of lung cancer in Ontario.
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Eary Diagnosis, Screening
- Medical subject headings
- Lung Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi C Roberts, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188734
- Sponsor's protocol ID
- I-ELCAP
- Status last verified
- Aug 2016
- First submitted
- 12 Sep 2005
- Last updated
- 10 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Screening in High-risk Smokers Using Low-dose Computed Tomography
- ClinicalTrials.gov ID
- NCT00188734
- Acronym / sponsor ID
- I-ELCAP
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Eary Diagnosis, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Sep 2005 (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.
Early detection of lung cancer may improve treatment outcomes. Risk factors have been identified, suggesting a population which might benefit from regular screening. Lung cancer screening using low-dose computed tomography (LDCT) has experienced a recent renaissance with reported sensitivity for detection of lung cancer of 2.7% in high-risk populations. The purpose of this study is to evaluate the utility of LCDT for the early diagnosis of lung cancer in Ontario.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- high risk current and former smokers
Key inclusion criteria (1 listed)
- 55 years or older at least 10 pack-year history of smoking general good health
Key exclusion criteria (1 listed)
- any prior cancers except non-melanotic skin cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 10 Aug 2016.
Related trials for Lung Cancer
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 1/2
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Non-small Cell Lung Cancer (NSCLC)
Active, not recruiting
Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)
Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer
KRAS Gene Mutation, Recurrent Lung Non-Small Cell Carcinoma
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.
Heidi C Roberts, MD principal investigator
University Health Network, Toronto
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 Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 1 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 10 Aug 2016. 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 Canada. 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.
Where can I read the original study information?
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 10 Aug 2016; AzTrials last refreshed its copy on 27 Oct 2026.