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Nashville Early Diagnosis Lung Cancer Project


N/A
55 Years
74 Years
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

Nashville Early Diagnosis Lung Cancer Project


It is proposed to test the hypotheses in a screening study of high risk individuals
(characterized by an established prediction rule). The expected prevalence of lung cancer in
this high risk group is estimated to be 2% per year. All individuals benefit from clinic
visit, low-dose Chest CT, spirometry and auto-fluorescence bronchoscopy at baseline, Chest
CT, follow-up doctor visit, and auto-fluorescence bronchoscopy at least at year 2 and 5.


Inclusion Criteria:



- 10 year Bach risk model >2.5%, (55 - 74 years of age, Current smoker with at least 25
years of smoking, at least 10 cigarettes/day, or Former smoker at least 20
pack-per-year (PPK) history of cigarette smoking total, who quit 20 years ago or
less)

- Plus one of the following:

- Forced expiratory volume in 1 second (FEV1) <70% predicted

- Or at least one first-degree relative with a diagnosis of lung cancer

- Or emphysema , moderate or severe

- Or history of resected lung cancer with no evidence of disease at 2 year follow up.

- Or history of treated head/neck and/or esophageal cancer with no evidence of disease
at 1 year post intervention.

Exclusion Criteria:

- History of diagnosis/treatment of lung cancer in the past 2 years or of head/neck or
esophageal cancer in the last 1 year.

- Inability to provide informed consent

- Chest CT within the last 12 months

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To compare candidate biomarkers over time among participants who did and did not develop lung cancer

Outcome 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.

Outcome Time Frame:

at baseline and yearly to year 5

Safety Issue:

No

Principal Investigator

Pierre P Massion, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

VICC THO 1078

NCT ID:

NCT01475500

Start Date:

April 2011

Completion Date:

November 2016

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms

Name

Location
Veterans Administration Nashville, Tennessee  37212
Vanderbilt University, Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232
Meharry Medical Center Nashville, Tennessee  37232