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

ConditionLung Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorVanderbilt-Ingram Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Inability to provide informed consent

Minors

Pregnant women

Trial population

People who may have lung cancer.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

comparative genomic hybridization
Genetic
Collection of sputum, blood, urine, and a small amount of lung tissue.
gene expression microarray analysis
Genetic
Collection of sputum, blood, urine, and a small amount of lung tissue.
proteomic profiling analysis
Genetic
Collection of sputum, blood, urine, and a small amount of lung tissue.
biologic sample preservation procedure
Other intervention
Collection of sputum, blood, urine, and a small amount of lung tissue.
nasal brushing
Procedure/Surgery
Using a brush, superficial cells are removed from the nose.
Blood draw
Procedure/Surgery
Venous blood will be collected
Urine collection
Procedure/Surgery
Subjects will be asked to provide a urine specimen.
sputum sample
Procedure/Surgery
Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up.
fluorescence bronchoscopy with airway biopsy
Procedure/Surgery
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.
fine needle aspiration of the lung
Procedure/Surgery
A small needle is inserted into the lung to collect tissue. This procedure will only be performed if the patient's physician orders it.
thoracentesis
Procedure/Surgery
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.

Treatment groups

4,000 Participants

are divided into 1 treatment group

Group A: Sample Collection11 interventions

Trial outcomes

Primary outcomes

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.

Time frame

After collection of designated samples

Secondary outcomes

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

Use of proteomic techniques in the laboratory to find a method of diagnosing lung tissue as benign or malignant rather than relying on invasive open-chest surgery for a diagnosis

Time frame

After collection of designated samples

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt-Ingram Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

Apply now