Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer

NCT00898313 | Recruiting

• 2 other identifiers: VICC THO 0398P30CA068485
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.

Conditions

Lung Cancer

Keywords

lung cancer

Outcome Measures

Primary Outcomes (1)

• To quantitate the molecular changes during lung cancer development

  As a part of the study nasal brushing specimens, sputum, blood, urine, and a small amount of other tissue will be collected during standard of care procedures (bronchial epithelial, trans-thoracic fine needle aspiration (FNA) and thoracentesis as part of patient work up. Clinical diagnosis is the primary goal of the procedure. All the research specimens are collected after the primary goal of the procedure is met.

  After collection of designated samples

Secondary Outcomes (1)

• Develop a method to diagnose and stage pre-invasive and invasive lesions

  After collection of designated samples

Study Arms (1)

Sample Collection

Genetic: comparative genomic hybridization; Genetic: gene expression microarray analysis; Genetic: proteomic profiling analysis; Other: biologic sample preservation procedure; Procedure: nasal brushing; Procedure: Blood draw; Procedure: Urine collection; Procedure: sputum sample; Procedure: fluorescence bronchoscopy with airway biopsy; Procedure: fine needle aspiration of the lung; Procedure: thoracentesis

Interventions

comparative genomic hybridization GENETIC

Collection of sputum, blood, urine, and a small amount of lung tissue.

Sample Collection

gene expression microarray analysis GENETIC

Collection of sputum, blood, urine, and a small amount of lung tissue.

Sample Collection

proteomic profiling analysis GENETIC

Collection of sputum, blood, urine, and a small amount of lung tissue.

Sample Collection

biologic sample preservation procedure OTHER

Collection of sputum, blood, urine, and a small amount of lung tissue.

Sample Collection

nasal brushing PROCEDURE

Using a brush, superficial cells are removed from the nose.

Sample Collection

Blood draw PROCEDURE

Venous blood will be collected

Sample Collection

Urine collection PROCEDURE

Subjects will be asked to provide a urine specimen.

Sample Collection

sputum sample PROCEDURE

Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up.

Sample Collection

fluorescence bronchoscopy with airway biopsy PROCEDURE

A flexible tube attached to a fluorescent light source will be inserted into the subject's mouth or nose to reach the airway. Samples of the lining of the airway will be taken, as well as bronchial secretions and epithelial cell from brushings of the lining of the airway.

Sample Collection

fine needle aspiration of the lung PROCEDURE

A small needle is inserted into the lung to collect tissue. This procedure will only be performed if the patient's physician orders it.

Sample Collection

thoracentesis PROCEDURE

A small needle is inserted into the patient's lung cavity and a small amount of fluid is collected. This procedure will only be performed if the patient's physician orders it.

Sample Collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who may have lung cancer.

You may qualify if:

• All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.

You may not qualify if:

• Inability to provide informed consent
• Minors
• Pregnant women

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37212, United States

RECRUITING

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, 37212, United States

RECRUITING

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, nasal cells, sputum, bronchal epithelial cells, airway tissue, and lung tissue

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Comparative Genomic Hybridization; Oligonucleotide Array Sequence Analysis; Blood Specimen Collection; Urine Specimen Collection; Thoracentesis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytogenetic Analysis; Genetic Techniques; Investigative Techniques; Molecular Diagnostic Techniques; Nucleic Acid Hybridization; Sequence Analysis; Microarray Analysis; Microchip Analytical Procedures; Molecular Probe Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Paracentesis; Therapeutics

Study Officials

• Fabien Maldonado, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Central Study Contacts

Vanderbilt Ingram Clinical Trials Information Program

CONTACT

1-800-811-8480

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Thoracic Surgery

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: December 1, 2003
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (2)