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

June 23, 2014 updated by: Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center

Molecular Predictors of Lung Cancer Behavior: Controls

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy, non-smokers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy, non-smokers
Genetic: proteomic profiling
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
Other: biologic sample preservation procedure
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
Other: laboratory biomarker analysis
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
Procedure: bronchoscopy
Collection of breath condensate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of biological specimens to use as controls in the study of lung cancer progression
Time Frame: Off study date, up to one year
Specimens are collected from healthy participants with no known risk of lung cancer
Off study date, up to one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
off-study date, up to one year
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
off-study date, up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC THO 0734
  • P30CA068485 (U.S. NIH Grant/Contract)
  • P50CA090949 (U.S. NIH Grant/Contract)
  • VU-VICC-THO-0734
  • VICC-THO-0734

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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