Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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

comparative genomic hybridization

gene expression microarray analysis

proteomic profiling analysis

biologic sample preservation procedure

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

nasal brushing

Blood draw

Subjects will be asked to provide a urine specimen.

Urine collection

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

sputum sample

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.

fluorescence bronchoscopy with airway biopsy

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

fine needle aspiration of the lung

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.

thoracentesis

Vanderbilt Ingram Clinical Trials Information Program

VICC Clinical Trials Information Program

Pierre Massion, MD

Research Office

Rena Burns, RN

Fabien Maldonado, MD

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.

OBJECTIVES:

* To use fixed lung tissue for histological evaluation and fresh tissue samples for molecular studies to study DNA, RNA, and protein abnormalities in lung preneoplastic and neoplastic lesions.
* To use proteomic techniques, including matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS), to develop a method of diagnosing and staging both pre-invasive and invasive lesions, using less invasive methods.

OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection.

Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.

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

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

Molecular Predictors of Lung Cancer Behavior

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.

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

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Professor of Medicine and Thoracic Surgery

Carcinoma

Carcinoma, Squamous Cell

Precancerous Conditions

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Lidocaine

The prospective SCC-PML cohort is envisioned to provide a well-matched group of high-risk subjects that will provide clinically comparable subjects with lesional sites representing progressive and non-progressive disease.

Bronchoscopy: Your nose, throat, vocal cords and windpipe are sprayed with Lidocaine (numbing medicine) to help keep you from coughing and to numb your airways. A tube with either a white light or the fluorescent light (bronchoscopy) is put down through your nose or mouth into your throat. Your nose, throat, vocal cords and lungs will be checked for any unusual areas while the tube goes down. You might have medicine sprayed into your mouth. You may be given a shot into your vein or muscle to help you be more comfortable.

Endobronchial Biopsy: Very tiny pieces of lung tissue (about the size of the head of a pin) will be taken from the lining of your lungs using forceps and a small brush. These tissues will be taken to a laboratory and tested.

Bronchoscopies

Subjects will be asked to perform the early morning spontaneous cough technique over a six-day period to provide for pre-screening evaluations. If moderate atypia is detected in a pre-screening specimen, additional sputum samples will be collected prior to each subsequent bronchoscopy. If this cannot be performed prior to bronchoscopy with adequate results, the sputum collection may be done after bronchoscopy. The sputum will be collected in containers containing Saccomanno's fixative.

Sputum Sample

Thirty milliliters of blood will be withdrawn from each subject, and the blood will be sent to the biorepository for analysis and storage.

Venipuncture

Brandi Kubala

Dakota Hitchcock, BA

Michele Baloneque-Siqueira, BA

Robert Keith, MD

This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas.

Via pre-screening, subjects at high risk for the development of lung squamous cell carcinoma (SCC) will be identified and enrolled to undergo serial bronchoscopies at 12 month intervals over a 2-3 year period. A variety of specimen types will be collected to support analyses of the genomic and microenvironmental features of these PMLs.

The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy

Prospective data collection of histologic specimens for the purposes of reducing lung cancer mortalities.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

University of Colorado, Denver

Dimercaprol

Chelating Agents

These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions

This is a collection of sputum (mucous) you cough up. Three morning samples will be collected at one time. Sputum will be collected at baseline, year 1, year 2 and year 5.

Sputum sample

A series of different breathing tests designed to measure lung function and to determine the presence or absence of chronic obstructive pulmonary disease will be performed at baseline.

Pulmonary function tests

A CT scan uses x-rays to take detailed pictures of the chest. Performed at baseline, year 2 and year 5. If nodules are present, CT scans will be performed every 3 months for the first year of the study.

Computerized tomography (CT) scan of the chest

Collect cells from the inside of the cheek. Samples will be collected at baseline and yearly to year 5.

Buccal epithelium collection

A cytobrush is used to remove cells on the surface of the inside of the nose. Samples will be collected at baseline and yearly to year 5.

Nasal brushings

A flexible tube with a light and a camera will be inserted through the nose or mouth, and into the lungs to look at the airway. Bronchial tissue will be obtained.

Bronchoscopy

During a bronchoscopy, a flexible tube with a light and a camera is passed through the mouth or nose into the lungs and fluid is squirted into a small part of the lung and collected for examination. Bronchoscopies will be performed at baseline and at year 5.

Bronchoalveolar lavage

A venous blood sample will be collected for testing of biomarkers and other relevant tests. Blood will be taken at baseline and yearly to year 5.

Blood sample collection

Urine will be collected for routine urine tests at baseline and yearly to year 5.

Urine sample

A questionnaire about the patient's health, medical, and smoking history. Administered at baseline and yearly to year 5. Data will be taken from patient interviews and from the medical record.

Questionnaire-data collection

Eric Grogan, MD

This screening study will address the lack of molecular strategies for the early detection of lung cancer and integrate those with epidemiological and imaging strategies.

The hypothesis is that the repeated measure of biomarkers of risk obtained from the molecular analysis of biological specimens including those from bronchoscopy (bronchial brushings and biopsies) may contribute to the refinement of high-risk populations and allow an earlier clinical diagnosis.

The goal of the investigators study is to provide screening for lung cancer in a high-risk population. In this prospective cohort it will be tested whether repeated measure of biomarkers of risk allows early detection of lung cancer.

It is proposed to test the hypotheses in a screening study of high risk individuals (characterized by an established prediction rule). The expected prevalence of lung cancer in this high risk group is estimated to be 2% per year. All individuals benefit from clinic visit, low-dose Chest CT, spirometry and auto-fluorescence bronchoscopy at baseline, Chest CT, follow-up doctor visit, and auto-fluorescence bronchoscopy at least at year 2 and 5.

Sputum, Blood, Urine, Nasal brushings, Buccal cells, Bronchical washings, Bronchioalveolar lavage brushings, Endobronchial biopsies

Nashville Early Diagnosis Lung Cancer Project

Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for biomarkers present in patients who develop lung cancer compared with those patients who do not develop lung cancer. Baseline and yearly screening results will be compared in the two groups.

Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for presently unknown biomarkers that occur in patients with lung cancer and in patients who do not have lung cancer but who may be at further increased risk of lung cancer.

Endobronchial tissue will be examined under a microscope for presence of changes in the cells that are abnormal but which are not invasive cancer.

Inclusion criteria for those patients who, based on their biomarker profile, are at increased risk of invasive lung cancer and who may benefit from clinical trials that will study chemoprevention strategies for lung cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer	NCT00898313	Lung Cancer	comparative gen... gene expression... proteomic profi... biologic sample... nasal brushing Blood draw Urine collectio... sputum sample fluorescence br... fine needle asp... thoracentesis	18 Years -	Vanderbilt-Ingram Cancer Center
Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer	NCT00898313	Lung Cancer	comparative gen... gene expression... proteomic profi... biologic sample... nasal brushing Blood draw Urine collectio... sputum sample fluorescence br... fine needle asp... thoracentesis	18 Years -	Vanderbilt-Ingram Cancer Center
The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy	NCT03881098	Lung Cancer	Bronchoscopies Sputum Sample Venipuncture	18 Years -	University of Colorado, Denver
Nashville Early Diagnosis Lung Cancer Project	NCT01475500	Lung Cancer	Sputum sample Pulmonary funct... Computerized to... Buccal epitheli... Nasal brushings Bronchoscopy Bronchoalveolar... Blood sample co... Urine sample Questionnaire-d...	55 Years - 80 Years	Vanderbilt-Ingram Cancer Center

Spots Global Cancer Trial Database for sputum sample