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CompletedNCT00899457Updated Jun 24, 2014

Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants

An observational study in Healthy, no Evidence of Disease and Lung Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-24.

Sponsored by Vanderbilt-Ingram Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
37
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about the development of cancer.

PURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer development using tissue samples from healthy participants.

Read the detailed description

OBJECTIVES:

  • To obtain biological specimens from healthy participants with no known risk of lung cancer to use as controls in the study of lung cancer progression.
  • To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.

OUTLINE: Serum, urine, sputum, and buccal cell samples are collected. Patients also undergo bronchoscopy for collection of bronchial tissue and bronchial brush samples. The samples are used for genomic and proteomic studies to identify new molecular abnormalities specific to the development of lung cancer.

02

Conditions studied

  • Healthy, no Evidence of Disease
  • Lung Cancer

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Keywords

  • squamous cell lung cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • healthy, no evidence of disease
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 37 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy, non-smokers.

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Healthy participant

    • No history of smoking
    • No history of cancer

PATIENT CHARACTERISTICS:

  • SWOG performance status 0
  • No clinically apparent bleeding diathesis

PRIOR CONCURRENT THERAPY:

  • Not specified
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
37 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy, non-smokers

    Genetic: proteomic profiling · Other: biologic sample preservation procedure · Other: laboratory biomarker analysis · Procedure: bronchoscopy

Interventions

  • Geneticproteomic profiling

    Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath

  • Otherbiologic sample preservation procedure

    Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath

  • Otherlaboratory biomarker analysis

    Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath

  • Procedurebronchoscopy

    Collection of breath condensate.

06

What researchers measure

Primary outcomes

  1. Collection of biological specimens to use as controls in the study of lung cancer progression

    Specimens are collected from healthy participants with no known risk of lung cancer

    Time frame: Off study date, up to one year

Secondary outcomes

  1. Identification of new molecular abnormalities specific to the development of squamous cell carcinoma of the lung

    Time frame: off-study date, up to one year

  2. Selection of important genes/proteins differentially expressed between study groups (e.g., normal vs low-grade vs high-grade vs invasive) and between normal smokers vs normal non-smokers

    Time frame: off-study date, up to one year

07

Study locations

3 sites
  • Vanderbilt-Ingram Cancer Center - Cool Springs
    Nashville, Tennessee 37064, United States
  • Vanderbilt-Ingram Cancer Center at Franklin
    Nashville, Tennessee 37064, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00899457
Lead sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Pierre P. Massion, MD (Associate Professor of Medicine (Allergy, Pulmonary & Critical Care) and Cancer Biology; Pulmonary and Critical Care Medicine Doctor, Vanderbilt-Ingram Cancer Center) — Principal investigator
First posted
May 12, 2009
Start date
Apr 2008
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Jun 24, 2014

Study contacts

Pierre P. Massion, MD
principal investigator · Vanderbilt-Ingram Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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