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

Molecular Predictors of Lung Cancer Behavior: Controls

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00899457
Enrollment
37
Registered
2009-05-12
Start date
2008-04-30
Completion date
2010-08-31
Last updated
2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, no Evidence of Disease, Lung Cancer

Keywords

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

Brief 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.

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.

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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt-Ingram Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Collection of biological specimens to use as controls in the study of lung cancer progressionOff study date, up to one yearSpecimens are collected from healthy participants with no known risk of lung cancer

Secondary

MeasureTime frame
Identification of new molecular abnormalities specific to the development of squamous cell carcinoma of the lungoff-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-smokersoff-study date, up to one year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026