Clinical trial · Observational
Nashville Early Diagnosis Lung Cancer Project
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This screening study will address the lack of molecular strategies for the early detection of lung cancer and integrate those with epidemiological and imaging strategies. The hypothesis is that the repeated measure of biomarkers of risk obtained from the molecular analysis of biological specimens including those from bronchoscopy (bronchial brushings and biopsies) may contribute to the refinement of high-risk populations and allow an earlier clinical diagnosis. The goal of the investigators study is to provide screening for lung cancer in a high-risk population. In this prospective cohort it will be tested whether repeated measure of biomarkers of risk allows early detection of lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample collection | Procedure | — | UNRESOLVED |
| Bronchoalveolar lavage | Procedure | — | UNRESOLVED |
| Bronchoscopy | Procedure | — | UNRESOLVED |
| Buccal epithelium collection | Other | — | UNRESOLVED |
| Computerized tomography (CT) scan of the chest | Radiation | — | UNRESOLVED |
| Nasal brushings | Procedure | — | UNRESOLVED |
| Pulmonary function tests | Procedure | — | UNRESOLVED |
| Questionnaire-data collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Screening
- description
- These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
- interventionNames
- Procedure: Sputum sample
- Procedure: Pulmonary function tests
- Radiation: Computerized tomography (CT) scan of the chest
- Other: Buccal epithelium collection
- Procedure: Nasal brushings
- Procedure: Bronchoscopy
- Procedure: Bronchoalveolar lavage
- Procedure: Blood sample collection
- Procedure: Urine sample
- Procedure: Questionnaire-data collection
Primary outcomes (1)
- measure
- To compare candidate biomarkers over time among participants who did and did not develop lung cancer
- timeFrame
- at baseline and yearly to year 5
- description
- Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for biomarkers present in patients who develop lung cancer compared with those patients who do not develop lung cancer. Baseline and yearly screening results will be compared in the two groups.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 55 - 80 years of age * Current smoker or former smoker. If former smoker, must have quit smoking less than 15 years ago * \>/= 30 pack year of smoking history Exclusion Criteria: * 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 * Participants in whom stopping anti-platelet or anti-coagulation therapy would have an adverse effect (DVT, mechanical heart valves, unstable coronary syndrome, etc.)
References
Publications (1)
- DERIVEDLakhani DA, Chen SC, Antic S, Muterspaugh A, Cook C, Liu N, Shujat H, Jouan S, Winston B, Fields K, Wenstrup J, Block SL, Hinton A, Miller A, Atmajoana S, Helton JT, Patel K, Balar AB, Brewer K, Nag S, Singh R, Disher A, Huerta L, Fremont R, Rickman O, Chen H, Eisenberg R, Sandler KL, Paulson A, Walker RC, Shah C, Smith GT, Landman B, Deppen S, Grogan EL, Aldrich MC, Massion PP. Establishing a Cohort and a Biorepository to Identify Biomarkers for Early Detection of Lung Cancer: The Nashville Lung Cancer Screening Trial Cohort. Ann Am Thorac Soc. 2021 Jul;18(7):1227-1234. doi: 10.1513/AnnalsATS.202004-344OC. PMID 33400907