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

NCT ID: NCT00899457

Last Updated: 2014-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy, no Evidence of Disease Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy, non-smokers

proteomic profiling

Intervention Type GENETIC

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

biologic sample preservation procedure

Intervention Type OTHER

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

laboratory biomarker analysis

Intervention Type OTHER

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

bronchoscopy

Intervention Type PROCEDURE

Collection of breath condensate.

Interventions

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proteomic profiling

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

Intervention Type GENETIC

biologic sample preservation procedure

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

Intervention Type OTHER

laboratory biomarker analysis

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

Intervention Type OTHER

bronchoscopy

Collection of breath condensate.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Pierre P. Massion, MD

Associate Professor of Medicine (Allergy, Pulmonary & Critical Care) and Cancer Biology; Pulmonary and Critical Care Medicine Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre P. Massion, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

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Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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P50CA090949

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VU-VICC-THO-0734

Identifier Type: -

Identifier Source: secondary_id

VICC-THO-0734

Identifier Type: -

Identifier Source: secondary_id

VICC THO 0734

Identifier Type: -

Identifier Source: org_study_id

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