Lung CancerNCT01130285
Validation of a Multi-gene Test for Lung Cancer Risk
An observational study of Lung Cancer, run by University of Toledo Health Science Campus at 13 sites in United States.
Trial summary
The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Lung Cancer Risk Test
- How many people
- 403 participants
- Where
- 13 sitesUnited States
- Study dates
- May 2011to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of subjects aged 50 to 90 and with 20 or more pack year smoking history, who are determined not to have lung cancer at the time of enrollment or within three months after the date of enrollment, and either a) volunteer for the study driven bronchoscopy, or b) have standard of care clinical need for diagnostic bronchoscopy (e.g. they may present with respiratory symptoms or abnormal test results consistent with the need for bronchoscopy).
Who may be able to join
- 20 or more pack year smoking history
- clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy
Who cannot join
- Lung Cancer within 3 months after the date of enrollment
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan
Ann Arbor, Michigan, 48109
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43221
National Jewish Health
Denver, Colorado, 80206
Henry Ford
Detroit, Michigan, 48202
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Tennessee Valley Veterans Admin.
Nashville, Tennessee, 37232
Vanderbilt
Nashville, Tennessee, 37232
Mayo Clinic
Rochester, Minnesota, 55905
The Toledo Hospital
Toledo, Ohio, 43606
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608
University of Toledo, Health Science Campus
Toledo, Ohio, 43614
About this study
The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.
Read the detailed description
Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.
- Conditions
- Lung Cancer
- Being tested
- Lung Cancer Risk Test
- Keywords
- 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.
Lung Cancer Risk TestGenetic
Also called LCRT
Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Non-Lung Cancer, Heavy Smoker | Subjects will be ≥ 50 years of age and have a ≥ 20 pack year smoking history and will be either healthy volunteers or individuals undergoing diagnostic bronchoscopy, with absence of lung cancer documented at the time of enrollment. Receives: Genetic: Lung Cancer Risk Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of LCRT to predict incidental lung cancer
Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT).
Measured: from time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMay 2011
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
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.
- 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
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James Willey, MD, Principal investigator, University of Toledo Health Science Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130285
- Sponsor's protocol ID
- UTHSC - 11
- Other IDs
- 1RC2CA148572-01
- Status last verified
- Jun 2025
- First submitted
- 24 May 2010
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Crawford EL, Levin A, Safi F, Lu M, Baugh A, Zhang X, Yeo J, Khuder SA, Boulos AM, Nana-Sinkam P, Massion PP, Arenberg DA, Midthun D, Mazzone PJ, Nathan SD, Wainz R, Silvestri G, Tita J, Willey JC. Lung cancer risk test trial: study design, participant baseline characteristics, bronchoscopy safety, and establishment of a biospecimen repository. BMC Pulm Med. 2016 Jan 22;16:16. doi: 10.1186/s12890-016-0178-4.
PubMed 26801409
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Multi-gene Test for Lung Cancer Risk
- ClinicalTrials.gov ID
- NCT01130285
- Acronym / sponsor ID
- UTHSC - 11
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 403 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2011
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 May 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 determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.
Detailed description
Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Lung Cancer, Heavy Smoker | – | Genetic: Lung Cancer Risk TestSubjects will be ≥ 50 years of age and have a ≥ 20 pack year smoking history and will be either healthy volunteers or individuals undergoing diagnostic bronchoscopy, with absence of lung cancer documented at the time of enrollment. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of subjects aged 50 to 90 and with 20 or more pack year smoking history, who are determined not to have lung cancer at the time of enrollment or within three months after the date of enrollment, and either a) volunteer for the study driven bronchoscopy, or b) have standard of care clinical need for diagnostic bronchoscopy (e.g. they may present with respiratory symptoms or abnormal test results consistent with the need for bronchoscopy).
Key inclusion criteria (2 listed)
- 20 or more pack year smoking history
- clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy
Key exclusion criteria (1 listed)
- Lung Cancer within 3 months after the date of enrollment
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 |
|---|---|---|
| Lung Cancer Risk TestAlso: LCRTMeasurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy. | Genetic | Non-Lung Cancer, Heavy Smoker |
Primary outcome
Accuracy of LCRT to predict incidental lung cancer
Time frame: from time of enrollment
Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 26801409Crawford EL, Levin A, Safi F, Lu M, Baugh A, Zhang X, Yeo J, Khuder SA, Boulos AM, Nana-Sinkam P, Massion PP, Arenberg DA, Midthun D, Mazzone PJ, Nathan SD, Wainz R, Silvestri G, Tita J, Willey JC. Lung cancer risk test trial: study design, participant baseline characteristics, bronchoscopy safety, and establishment of a biospecimen repository. BMC Pulm Med. 2016 Jan 22;16:16. doi: 10.1186/s12890-016-0178-4.
- Individual participant dataSharing planned: No
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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.
James Willey, MD principal investigator
University of Toledo Health Science Campus
13 sites 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 of Toledo Health Science Campus at 13 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 2 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
This study is still under way. Results are not available in the source record yet.
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?
Accuracy of LCRT to predict incidental lung cancer (time frame: from time of enrollment). 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 NCT01130285, 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 10 Jun 2025.