Lung CancerNCT00596310
Early Detection of Lung Cancer in a High-Risk Population Defined by PFT, Biomarkers, and CT Scanning
A study testing CT in people with Lung Cancer, run by Susanne Arnold at 4 sites in United States.
Trial summary
Lung cancer is the number one cancer killer in Kentucky and has a very high incidence within the 5th Congressional District of Kentucky (110.8 cases per 100,000 in period 1996-2000). Surgical removal provides the best chance for cure. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 531 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2004to Jan 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55-75 years old.
- Identification of a primary care physician (can be identified by study staff if needed).
- FEV1/FVC <70% (GOLD 1 or higher COPD) (poor breathing function).
- > or = 40 pack-year current or former (within the last 10 years) tobacco use (i.e. heavy cigarette smoking history).
Who cannot join
- Enrolled in any other lung screening or lung cancer prevention trial.
- Chest CT within the prior 12 months.
- Inability to lie flat with arms raised above the head.
- Current or prior personal history of lung cancer.
- Prior history of cancer within the last five years or currently receiving treatment for cancer, except adequately treated non-melanomatous skin cancer or in-situ cervical cancer.
- Life expectancy of less than 5 years.
- Patients requiring supplemental oxygen.
- Inability to give informed consent.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hazard ARH Regional Medical Center
Hazard, Kentucky, 41702
St. Claire Regional Medical Center
Morehead, Kentucky, 40351
Highlands Regional Medical Center
Prestonsburg, Kentucky, 41653
Lake Cumberland Regional Hospital
Somerset, Kentucky, 42501
About this study
Official title: Early Detection of Lung Cancer in a High-Risk Population Defined by Pulmonary Function Testing, Biomarkers, and Computerized Tomography Scanning
Lung cancer is the number one cancer killer in Kentucky and has a very high incidence within the 5th Congressional District of Kentucky (110.8 cases per 100,000 in period 1996-2000). Surgical removal provides the best chance for cure. Unfortunately, the majority of lung cancer cases are detected in an advanced stage, when surgical resection is impossible. This leads to shorter survival rates and increased mortality rates for lung cancer, increased patient suffering, and greater cost to the healthcare system. Methods that favor earlier detection are therefore crucial for successful treatment. One such method, low-dose spiral computed tomography (CT) is being studied to determine whether its use as a screening method will lead to earlier detection and earlier intervention, perhaps impacting survival and mortality in lung cancer. This method has a modest sensitivity to detect lung cancer, but low specificity, which leads to many false positives and a low negative predictive value. The present study is designed to address both of these limitations by: 1) identifying individuals in the population at highest risk for developing lung cancer (due to smoking habits and decreased pulmonary function) for subsequent CT screening, and 2) performing biomarker testing in conjunction with the CT scan to improve the ability to discern individuals with benign lung nodules from those with malignant tumors. The 5th Congressional District of Kentucky has one of the highest rates of lung cancer in the nation and is an ideal location to test the validity (sensitivity and specificity), feasibility (negative and positive predictive value), and efficacy (stage distribution shift to earlier stage disease, increased survival, and decreased cancer-specific mortality) of these strategies to enhance early detection.
- Conditions
- Lung Cancer
- Being tested
- CT
- Keywords
- Lung cancer, screening
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTOther
Screening CT
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Screening CT Receives: Other: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
test validity
Measured: 5 years
Secondary outcomes (2)
test feasibility
Measured: 5 years
test efficacy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startNov 2004
- Primary completionDec 2016
- Study completionJan 2020
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Arnold
- Sponsor type
- University, hospital or other
- Collaborators
- Marty Driesler Cancer Project, Kentucky Lung Cancer Research Program
- Responsible party
- Sponsor-investigator, Susanne Arnold, University of Kentucky
- Investigators
- Susanne Arnold, M.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596310
- Sponsor's protocol ID
- MDCP-Lung
- Status last verified
- Feb 2020
- First submitted
- 7 Jan 2008
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Lung Cancer in a High-Risk Population Defined by Pulmonary Function Testing, Biomarkers, and Computerized Tomography Scanning
- ClinicalTrials.gov ID
- NCT00596310
- Acronym / sponsor ID
- MDCP-Lung
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Susanne ArnoldUniversity, hospital or other
- Collaborators
- Marty Driesler Cancer Project, Kentucky Lung Cancer Research Program
- Study start
- Nov 2004 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 16 Jan 2008 (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.
Lung cancer is the number one cancer killer in Kentucky and has a very high incidence within the 5th Congressional District of Kentucky (110.8 cases per 100,000 in period 1996-2000). Surgical removal provides the best chance for cure. Unfortunately, the majority of lung cancer cases are detected in an advanced stage, when surgical resection is impossible. This leads to shorter survival rates and increased mortality rates for lung cancer, increased patient suffering, and greater cost to the healthcare system. Methods that favor earlier detection are therefore crucial for successful treatment. One such method, low-dose spiral computed tomography (CT) is being studied to determine whether its use as a screening method will lead to earlier detection and earlier intervention, perhaps impacting survival and mortality in lung cancer. This method has a modest sensitivity to detect lung cancer, but low specificity, which leads to many false positives and a low negative predictive value. The present study is designed to address both of these limitations by: 1) identifying individuals in the population at highest risk for developing lung cancer (due to smoking habits and decreased pulmonary function) for subsequent CT screening, and 2) performing biomarker testing in conjunction with the CT scan to improve the ability to discern individuals with benign lung nodules from those with malignant tumors. The 5th Congressional District of Kentucky has one of the highest rates of lung cancer in the nation and is an ideal location to test the validity (sensitivity and specificity), feasibility (negative and positive predictive value), and efficacy (stage distribution shift to earlier stage disease, increased survival, and decreased cancer-specific mortality) of these strategies to enhance early detection.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: CTScreening CT |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55-75 years old.
- Identification of a primary care physician (can be identified by study staff if needed).
- FEV1/FVC <70% (GOLD 1 or higher COPD) (poor breathing function).
- > or = 40 pack-year current or former (within the last 10 years) tobacco use (i.e. heavy cigarette smoking history).
Key exclusion criteria (8 listed)
- Enrolled in any other lung screening or lung cancer prevention trial.
- Chest CT within the prior 12 months.
- Inability to lie flat with arms raised above the head.
- Current or prior personal history of lung cancer.
- Prior history of cancer within the last five years or currently receiving treatment for cancer, except adequately treated non-melanomatous skin cancer or in-situ cervical cancer.
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 |
|---|---|---|
| CTScreening CT | Other | 1 |
Primary outcome
test validity
Time frame: 5 years
2 secondary outcomes
test feasibility
Time frame: 5 years
test efficacy
Time frame: 5 years
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 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Susanne Arnold, M.D. principal investigator
University of Kentucky
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT in people with Lung Cancer, run by Susanne Arnold at 4 sites in United States.
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 4 inclusion and 8 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 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
test validity (time frame: 5 years). It is what the study was designed to measure, not a finding.
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 13 Feb 2020.