Lung CancerNCT03683940
Pilot Study of High Risk Lung Cancer Screening
A study testing Screening in people with Lung Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines. Read more about this study
- Who is it for?
- Ages 40 to 82 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2016to 9 Nov 2023
- 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 40 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 40-82 yrs of age.
- Presenting for lung cancer screening evaluation.
- Calculated 6 yr lung cancer risk >1.5% for patients 40-77 years of age or >4% for patients 78-82 years of age.
- Able and willing to provide informed consent.
Who cannot join
- Eligible for clinically indicated lung cancer screening (55-80 yr old, >30 pky smoking history, still smoking or quit smoking within the last 15 yr).
- Chest CT performed within the last year.
- Life expectancy less than 6 months.
- Symptoms clinically consistent with lung cancer.
- Unable or unwilling to undergo treatment for lung cancer.
- Any individual who does not give oral and written consent for participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Denver, Colorado, 80045
About this study
Official title: A Prospective Pilot Study of Lung Cancer Screening in Patients at High Risk for Lung Cancer Who Do Not Meet Current Screening Guidelines
This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines.
Read the detailed description
This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines. Potential subject's 6 yr lung cancer risk must exceed 1.5% by the Tammamagi PLCO2012m calculator. Patients will undergo a non contrast CT chest for lung cancer screening. This cutoff should encompass in excess of 80% of all lung cancer cases (10). However, in patients 78-82 years old we will set the 6 yr lung cancer risk threshold at 4.0% as these patients will typically have other competing risks of death and this may potentially limit screening benefit in these older individuals.
- Conditions
- Lung Cancer
- Being tested
- Screening
- Keywords
- Pilot Study, High Risk, Prospective, 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.
ScreeningDiagnostic test
Subjects will undergo a low dose non contrast CT chest for lung cancer screening. The test will be performed by the UCH Radiology Department and read by board-certified chest radiologists using Lung-RADS criteria.
| Study group | Role | What they receive |
|---|---|---|
| Screening | Other | Subjects will undergo a low dose non contrast CT chest for lung cancer screening. Receives: Diagnostic Test: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Cancer Screening
Prospectively identify patients for lung cancer screening using risk calculators
Measured: Duration of the study, up to 3 years
Medical Outcomes
Evaluate health outcomes of CT screening by assessing the number and stage of lung cancers detected by screening using Lung-RADS criteria
Measured: Duration of the study, up to 3 years
Medical Outcomes
Evaluate health outcomes of CT screening by assessing the number and stage the spectrum of other radiographic abnormalities detected using Lung-RADS criteria
Measured: Duration of the study, up to 3 years
Economic Outcomes
Evaluate the costs associated with managing lung cancers detected by screening
Measured: Duration of the study, up to 3 years
Economic Outcomes
Evaluate the costs associated with managing the spectrum of other radiographic abnormalities
Measured: Duration of the study, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start10 Aug 2016
- Primary completion25 Apr 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa New, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683940
- Sponsor's protocol ID
- 15-1694.cc
- Status last verified
- Dec 2023
- First submitted
- 24 Sep 2018
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hirsch EA, New ML, Brown SL, Malkoski SP. Results of a pilot risk-based lung cancer screening study: outcomes and comparisons to a Medicare eligible cohort. Discov Oncol. 2023 Aug 29;14(1):160. doi: 10.1007/s12672-023-00773-5.
PubMed 37642787
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study of Lung Cancer Screening in Patients at High Risk for Lung Cancer Who Do Not Meet Current Screening Guidelines
- ClinicalTrials.gov ID
- NCT03683940
- Acronym / sponsor ID
- 15-1694.cc
- Conditions
- Lung Cancer
- Keywords
- Pilot Study, High Risk, Prospective, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 25 Sep 2018 (actual)
- 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.
This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines.
Detailed description
This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines. Potential subject's 6 yr lung cancer risk must exceed 1.5% by the Tammamagi PLCO2012m calculator. Patients will undergo a non contrast CT chest for lung cancer screening. This cutoff should encompass in excess of 80% of all lung cancer cases (10). However, in patients 78-82 years old we will set the 6 yr lung cancer risk threshold at 4.0% as these patients will typically have other competing risks of death and this may potentially limit screening benefit in these older individuals.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | Other | Diagnostic Test: ScreeningSubjects will undergo a low dose non contrast CT chest for lung cancer screening. |
Who may qualify
- Ages
- 40 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult 40-82 yrs of age.
- Presenting for lung cancer screening evaluation.
- Calculated 6 yr lung cancer risk >1.5% for patients 40-77 years of age or >4% for patients 78-82 years of age.
- Able and willing to provide informed consent.
Key exclusion criteria (6 listed)
- Eligible for clinically indicated lung cancer screening (55-80 yr old, >30 pky smoking history, still smoking or quit smoking within the last 15 yr).
- Chest CT performed within the last year.
- Life expectancy less than 6 months.
- Symptoms clinically consistent with lung cancer.
- Unable or unwilling to undergo treatment for lung 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 |
|---|---|---|
| ScreeningSubjects will undergo a low dose non contrast CT chest for lung cancer screening. The test will be performed by the UCH Radiology Department and read by board-certified chest radiologists using Lung-RADS criteria. | Diagnostic test | Screening |
Primary outcome
Lung Cancer Screening
Time frame: Duration of the study, up to 3 years
Prospectively identify patients for lung cancer screening using risk calculators
Medical Outcomes
Time frame: Duration of the study, up to 3 years
Evaluate health outcomes of CT screening by assessing the number and stage of lung cancers detected by screening using Lung-RADS criteria
Medical Outcomes
Time frame: Duration of the study, up to 3 years
Evaluate health outcomes of CT screening by assessing the number and stage the spectrum of other radiographic abnormalities detected using Lung-RADS criteria
Economic Outcomes
Time frame: Duration of the study, up to 3 years
Evaluate the costs associated with managing lung cancers detected by screening
Economic Outcomes
Time frame: Duration of the study, up to 3 years
Evaluate the costs associated with managing the spectrum of other radiographic abnormalities
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 12 Dec 2023.
- Derived from this study: PubMed 37642787Hirsch EA, New ML, Brown SL, Malkoski SP. Results of a pilot risk-based lung cancer screening study: outcomes and comparisons to a Medicare eligible cohort. Discov Oncol. 2023 Aug 29;14(1):160. doi: 10.1007/s12672-023-00773-5.
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.
Melissa New, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening in people with Lung Cancer, run by University of Colorado, Denver at 1 site 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 6 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 12 Dec 2023. 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 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?
Lung Cancer Screening (time frame: Duration of the study, up to 3 years). The study lists 5 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 NCT03683940, which also lists 1 linked publication.
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 12 Dec 2023.