Lung CancerNCT03181256
Early Detection of Lung Cancer
An observational study of Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Biospecimen Collection, Pulmonary Function Test and Computed Tomography (CT)
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2017to 9 Nov 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 55 to 80 years
- All sexes
- Adult, Older adult
Study population: Current or former smokers
Who may be able to join
- Current smoker or former smoker, if former smoker participants must have quit smoking within the past 15 years
- >= 30 pack year of smoking history
- Participant is uninsured
Who cannot join
- History of diagnosis/treatment of lung cancer in the past 2 years
- History of head/neck or esophageal cancer in the last 1 year
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Early Detection of Lung Cancer in the Medically Underserved Population
This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.
Read the detailed description
PRIMARY OBJECTIVES:
- To provide screening for lung cancer in an underserved and high risk population for lung cancer.
II. To collect clinical and demographic information and research bio specimens prospectively on high risk individuals.
III. To analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer.
IV. To identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions.
- To assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers.
VI. To describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention).
OUTLINE:
Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records.
- Conditions
- Lung Cancer
- Being tested
- Biospecimen Collection, Pulmonary Function Test, Computed Tomography (CT), Laboratory Biomarker
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of sputum
Biospecimen collectionProcedure or surgery
Undergo collection of nasal epithelium
Biospecimen collectionProcedure or surgery
Undergo collection of buccal epithelium
Biospecimen collectionProcedure or surgery
Undergo collection of blood
Biospecimen collectionProcedure or surgery
Undergo collection of urine
Pulmonary Function TestProcedure or surgery
Undergo pulmonary function test
Computed Tomography (CT)Procedure or surgery
Also called Undergo chest CT
Undergo chest CT
Laboratory BiomarkerOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Screening | Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records Receives: Procedure: Biospecimen Collection; Procedure: Pulmonary Function Test; Procedure: Computed Tomography (CT); Other: Laboratory Biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Candidate biomarkers of risk or of early diagnosis
Will validate the performance of the candidate biomarkers of risk or of early diagnosis.
Measured: Up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start14 Dec 2017
- Primary completion30 Nov 2023
- Study completion9 Nov 2026 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Eric Grogan, Vanderbilt-Ingram Cancer Center
- Investigators
- Eric Grogan, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181256
- Sponsor's protocol ID
- VICC THO 1730
- Other IDs
- NCI-2017-00889, CA152662
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2017
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Lung Cancer in the Medically Underserved Population
- ClinicalTrials.gov ID
- NCT03181256
- Acronym / sponsor ID
- VICC THO 1730
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 9 Nov 2026 (estimated)
- First posted
- 8 Jun 2017 (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 research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.
Detailed description
PRIMARY OBJECTIVES:
- To provide screening for lung cancer in an underserved and high risk population for lung cancer.
II. To collect clinical and demographic information and research bio specimens prospectively on high risk individuals.
III. To analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer.
IV. To identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions.
- To assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers.
VI. To describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention).
OUTLINE:
Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | – | Procedure: Biospecimen Collection, Procedure: Pulmonary Function Test, Procedure: Computed Tomography (CT), Other: Laboratory BiomarkerPatients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Current or former smokers
Key inclusion criteria (3 listed)
- Current smoker or former smoker, if former smoker participants must have quit smoking within the past 15 years
- >= 30 pack year of smoking history
- Participant is uninsured
Key exclusion criteria (3 listed)
- History of diagnosis/treatment of lung cancer in the past 2 years
- History of head/neck or esophageal cancer in the last 1 year
- Inability to provide informed consent
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 |
|---|---|---|
| Biospecimen CollectionUndergo collection of sputum | Procedure or surgery | Screening |
| Biospecimen collectionUndergo collection of nasal epithelium | Procedure or surgery | Screening |
| Biospecimen collectionUndergo collection of buccal epithelium | Procedure or surgery | Screening |
| Biospecimen collectionUndergo collection of blood | Procedure or surgery | Screening |
| Biospecimen collectionUndergo collection of urine | Procedure or surgery | Screening |
| Pulmonary Function TestUndergo pulmonary function test | Procedure or surgery | Screening |
| Computed Tomography (CT)Also: Undergo chest CTUndergo chest CT | Procedure or surgery | Screening |
| Laboratory BiomarkerCorrelative studies | Other | Screening |
Primary outcome
Candidate biomarkers of risk or of early diagnosis
Time frame: Up to 5 years.
Will validate the performance of the candidate biomarkers of risk or of early diagnosis.
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 5 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
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.
Eric Grogan, MD principal investigator
Vanderbilt-Ingram Cancer Center
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 Vanderbilt-Ingram Cancer Center 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 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. 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?
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?
Candidate biomarkers of risk or of early diagnosis (time frame: Up to 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 5 May 2026.