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INS316

sputum cytology

Jenny T. Mao, MD

RATIONALE: INS316 may produce a better sputum sample for laboratory analysis and may provide a less invasive method of diagnosing lung cancer.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of INS316 with that of saline for sputum collection in diagnosing lung cancer in patients suspected of having lung cancer.

OBJECTIVES:

* Compare the number of lung cancer diagnoses obtained from cytological evaluation of sputum expectorated after inhalation of INS316 versus normal saline as an adjunct for spontaneous expectoration of sputum in patients with suspected lung cancer.
* Compare the relative sensitivity of sputum cytology in the diagnosis of primary lung cancer using these methods of sputum collection in these patients.
* Compare the amount of sputum collected from patients using these methods.
* Correlate the number of macrophages in sputum with the predictive likelihood of obtaining a positive diagnosis by sputum cytology in these patients.
* Determine whether specificity of sputum cytology is adversely affected by induction with INS316 in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel, multicenter study. Patients are stratified according to tumor size and location as visualized by chest radiography, CT scan, or positron-emission tomography scan (peripheral tumor (distal to the subsegmental bronchi) no greater than 2 cm in diameter vs peripheral tumor greater than 2 cm in diameter vs central tumor no greater than 2 cm in diameter vs central tumor greater than 2 cm in diameter). Patients are randomized to one of two arms.

Prior to dosing with sputum induction adjunct, all patients expectorate sputum spontaneously.

* Arm I: Patients receive a single dose of INS316 by inhalation.
* Arm II: Patients receive a single dose of placebo (normal saline) by inhalation.

In both arms, patients expectorate sputum during dosing, immediately after dosing, and then within 15, 30, and 60 minutes after dosing.

Patients are followed on day 1 after dosing, for up to 8 weeks until a diagnosis is made, and then up to 3 months if diagnosis is malignant.

PROJECTED ACCRUAL: Approximately 800 patients (or until 600 confirmed diagnoses of malignancy are made) will be accrued for this study.

INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer

A Double-Blinded, Placebo-Controlled, Parallel Group Study Of Uridine 5'-Triphosphate (UTP) Solution For Inhalation As An Adjunct In The Diagnosis Of Lung Cancer By Sputum Cytology

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Mouth Neoplasms

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

cytology specimen collection procedure

immunohistochemistry staining method

bronchoscopic and lung imaging studies

bronchoscopy

comparison of screening methods

endoscopic biopsy

J. Michael Hamilton, MD

RATIONALE: Fluorescent bronchoscopy, when used in combination with conventional white light bronchoscopy, may improve the ability to detect early lung cancer.

PURPOSE: A pilot study to evaluate fluorescent light bronchoscopy plus conventional bronchoscopy as a tool for screening and detecting lung cancer in persons with completely resected head and neck cancer or successfully treated early-stage lung cancer.

OBJECTIVES:

* Evaluate the efficacy of autofluorescence bronchoscopy using the Lung Imaging Fluorescence Endoscopic System with conventional white-light bronchoscopy for the early detection of lung cancer in selected patients with known or suspected bronchogenic carcinoma, completely resected head and neck cancer, and successfully treated early-stage lung cancer.
* Determine the number of areas of moderate dysplasia, severe dysplasia, and carcinoma in situ in patients treated with surgery for lung cancer compared with patients treated with combined modality therapy.
* Determine the ability of immunohistochemistry to predict whether lesions of moderate to severe dysplasia will progress to cancer.

OUTLINE: If possible, patients produce a 3-day pooled sputum sample prior to bronchoscopy. Patients then undergo tracheobronchial white-light bronchoscopy followed by autofluorescence bronchoscopy using the Lung Imaging Fluorescence Endoscopic (LIFE) Device attached to a computerized video camera. Visualized tissue is classified as either normal, abnormal, or suspicious. Abnormal or suspicious tissue is biopsied, as is tissue from 1 or 2 randomly chosen normal sites. Immunohistochemical analysis of the biopsy material is conducted without knowledge of the bronchoscopic results. Patients unable to produce a sputum sample prior to bronchoscopy are required to do so after bronchoscopy.

PROJECTED ACCRUAL: A total of 70 patients will be entered.

Fluorescent Light Bronchoscopy Plus White Light Bronchoscopy for Early Detection of Lung Cancer

PILOT STUDY OF THE CORRELATION BETWEEN THE FINDINGS OF ATYPICAL/MALIGNANT CELLS IN SPUTUM AND FLUORESCENCE BRONCHOSCOPY IN PATIENTS AT RISK FOR LUNG CANCER OF THE LIFE IMAGING SYSTEM AND WHITE LIGHT BRONCHOSCOPY

Digestive System Diseases

Esophageal Neoplasms

Precancerous Conditions

Carcinoid Tumor

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Tongue Cancer

Metastatic Squamous Neck Cancer With Occult Primary

laboratory biomarker analysis

biopsy

Brandi Kubala

Clinical Trials Office - University of Colorado Cancer Center

York E. Miller, MD

RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with dysplasia or cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help the study of cancer in the future.

PURPOSE: This laboratory study is looking at biomarkers in patients with respiratory tract dysplasia or lung cancer, head and neck cancer, or aerodigestive tract cancer.

OBJECTIVES:

Primary

* Determine intermediate biomarkers of premalignant respiratory epithelial lesions, such as genetic mutations or altered growth factor expression, in patients with dysplasia of the respiratory epithelium or lung cancer, head and neck cancer, or aerodigestive tract cancer.

Secondary

* Establish a tissue repository of normal and dysplastic respiratory epithelium from endobronchial forceps and brush biopsy tissue from these patients and from normal volunteers.

OUTLINE: Patients are stratified according to presence of extensive and severe dysplasia of the respiratory epithelium (yes vs no).

Participants undergo sputum cytology, white-light (with or without fluorescence) bronchoscopy, and endobronchial biopsies. Participants also undergo endobronchial brushings and bronchial secretion collection and possibly bronchoalveolar lavage. Collected samples are processed by hematoxylin, eosin, and immunohistochemical staining and analyzed for specific biomarkers. Unused samples are stored in the tissue bank.

PROJECTED ACCRUAL: A total of 330 participants will be accrued for this study.

Sputum sample, Endobronchial biopsy, bronchial secretions, pulmonary lavage, blood and urine.

Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers

Biomarkers and Dysplastic Respiratory Epithelium

University of Colorado, Denver

Dimercaprol

Chelating Agents

bronchoalveolar lavage

screening questionnaire administration

computed tomography

study of high risk factors

Abraham Chachoua, MD

RATIONALE: Imaging procedures such as computed tomography may improve the ability to detect lung cancer earlier.

PURPOSE: Screening and diagnostic study of computed tomography in women who are at risk for lung cancer.

OBJECTIVES:

* Determine the ability of computed tomography (CT) to detect early lung parenchymal abnormalities in women at high risk for lung cancer.
* Determine the number of abnormal findings detected by CT that develop into lung cancer in these patients.
* Correlate these abnormalities with the presence of K-ras and p53 mutations in the sputum and bronchoalveolar lavage in these patients.
* Develop and implement appropriate educational materials regarding lung cancer in women and provide referrals to other programs, such as smoking cessation programs.

OUTLINE: Patients complete a questionnaire at baseline to assess demographics, medical history, smoking history, menopausal status, estrogen therapy, and diet.

Patients then undergo a low-dose computed tomography (CT) scan without contrast. Patients with normal CT results undergo additional CT scans every 12 months.

Patients with abnormal CT results undergo a diagnostic CT scan (in the absence of prior studies). Patients with indeterminate nodules (less than 5 mm in size) undergo surveillance CT studies within 3-4 months. If nodules remain unchanged in size, patients undergo additional surveillance CT studies at 6 months and 1 year. Patients with lung parenchymal abnormalities on CT suspicious for malignancy undergo a bronchoscopy with biopsy and bronchoalveolar lavage (BAL). Patients with abnormal CT scan(s) and negative BAL for p53 and/or K-ras mutations or normal histology and positive BAL for K-ras and/or p53 mutations undergo additional CT scans at 6 months and 1 year. Patients with biopsy-proven malignancy after bronchoscopy are referred for definitive treatment.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer

Prevention and Early Detection of Lung Cancer in Women

NYU Langone Health

Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent \[ie, cancer\] cells (RFCs) from deep-lung sputum samples.

CyPath diagnostic assay for the early detection of lung cancer using sputum

CyPath

Constance Dorian, BS Biology

Lara Patriquin, MD

Thomas Bauer, MD

Primary Objective:

* To determine the clinical sensitivity and specificity of the Biomoda CyPath™ Early Lung Cancer Detection Assay using sputum specimens from two cohorts of participants and estimate the required sample size to finalize a protocol for a pivotal study.

Secondary Objectives:

* To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay in a clinical setting to identify cancer cells, as assessed by TCPP labeled cancer cells demonstrating red fluorescence under a microscope with ultraviolet (UV) light being observed with a FITC (Fluorescein isothiocyanate) Filter.
* To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay to detect pre-invasive cancer in comparison with PAP sputum cytology and routine CT scan.

Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) is a porphyrin that can label cancer cells by reacting to the increased number of low-density lipoproteins coating the surface of cancer cells and the porous nature of the cancer cell membrane, causing the cell to fluoresce under specific wavelengths of light. The primary objective of this clinical trial was to determine the clinical sensitivity and specificity of the CyPath® Lung Cancer Detection Assay ("CyPath® Assay") using sputum specimens from two cohorts of Participants. The Study design included a protocol to assess the capability of the Biomoda CyPath® Lung Cancer Detection Assay to detect cancer in comparison with routine high-resolution, low-dose Computed Tomography (LDCT) scans.

Optimization of the Assay can lead to improved sensitivity and specificity. Increase in sample size and evaluation of the entire sputum sample can increase data collection and differentiation between cohorts. Technicians in the current Study examined 12 slides containing approximately 600,000 cells. The average sputum sample pellet translates to a potential of approximately 3.5 million cells for evaluation. Evaluating the full sputum sample with the CyPath® Assay can be accomplished through flow cytometry and would increase the capture and analysis of exfoliated cancer cells in the sample. In-house studies evaluated samples from five different cancer cell lines using flow cytometry. Preliminary results showed that cancer cell lines were detected with significant fluorescence apart from normal cell fluorescence. Refinements for using the flow cytometer include optimizing the liquid-based assay and sample analysis and focus on concentration, incubation time and optimal sample volume.

Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer

Various measurements were taken to report the validity of the findings. Sensitivity in this study was defined as the percentage of tumor cells that were positively identified. Specificity was the percentage of true positive signals and accuracy calculated as the percentage of those patients identified as having cancer.

Testing for the study was performed at multiple locations to assess the efficacy of the CyPath Assay to detect lung cancer cells exfoliated from lung tumors present in deep-lung sputum. Participants who satisfied the inclusion/exclusion criteria were enrolled in the study and assigned to one of two cohorts (smoker with clear Low dose CT scan or "high-risk" normals," and lung cancer confirmed by pathology or "cancer").

Alquest

Quintiles, Inc.

Radiology Associates of Albuquerque

New Mexico Technical Institute of Mining and Technology

US Department of Veterans Affairs

Biomoda Inc.

Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent \[ie, cancer\] cells (RFCs) from deep-lung sputum samples.

CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum

Single Arm Labeling of Deep-Lung Sputum Samples With TCPP

cohort 1 n=102

cohort 2 n=26

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Male and female subjects aged 18 years of age and older were recruited from the pool of United States' military veterans who responded to public advertisements and recruitment pamphlets disseminated at veteran's events,

Maria Zannes

Sensitivity

Specificity

Accuracy

Determine the Clinical Sensitivity and Specificity of the Biomoda CyPath™ Early Lung Cancer Detection Assay Using Sputum Specimens From Two Cohorts of Participants and Estimate the Required Sample Size to Finalize a Protocol for a Pivotal Study.

Overall Study

Substance Related Disorders

Behaviors and Mental Disorders

Tobacco Use Disorder

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Fourier transform infrared spectroscopy

diagnostic bronchoscopy

Contact Person

Paul D. Lewis, BSc, PhD

RATIONALE: Collecting and storing samples of sputum and tissue to study in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking samples of sputum and tissue from lung cancer patients, participants at high risk for developing lung cancer, and from healthy volunteers (both smokers and non-smokers).

OBJECTIVES:

* To test and make a preliminary assessment of the sensitivity and specificity of Fourier transform infrared technology (FTIR) for use in the early detection of lung cancer in sputum samples from patients who have or participants at high risk for developing lung cancer and from non-high-risk smoking and non-smoking volunteers.
* To permit identification of specific metabolic biomarkers within FTIR spectra that can distinguish between lung cancer, high-risk, and non-high-risk cases.

OUTLINE: This is a multicenter study.

Sputum samples and endobronchial biopsy tissue specimens are collected prior to routine bronchoscopy as part of a standard clinical assessment for the early detection of lung cancer. Sputum samples are examined for levels of bronchial and non-bronchial cells using established cytological and immunohistochemical procedures. Samples are also examined for metabolic biomarkers using Fourier transform infrared spectroscopy (FTIR) to generate complete metabolic fingerprints (i.e., spectra) that can distinguish metabolic differences between cancer, non-cancer, and early disease (i.e., dysplasia or metaplasia). These molecular biomarkers, which are detected within FTIR spectra, may be further analyzed in matched endobronchial biopsy tissue samples for histological confirmation. Additional clinico-pathological data is collected for each participant to allow development of predictive statistical models from the data.

All study participants are followed annually.

Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers

Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)

South West Wales Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer	NCT00033527	Lung Cancer	INS316 sputum cytology	18 Years -	National Cancer Institute (NCI)
Fluorescent Light Bronchoscopy Plus White Light Bronchoscopy for Early Detection of Lung Cancer	NCT00019201	Head and Neck C... Lung Cancer	cytology specim... immunohistochem... sputum cytology bronchoscopic a... bronchoscopy comparison of s... endoscopic biop...	18 Years -	National Cancer Institute (NCI)
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers	NCT00900419	Esophageal Canc... Head and Neck C... Lung Cancer Precancerous Co...	immunohistochem... laboratory biom... sputum cytology biopsy	21 Years - 90 Years	University of Colorado, Denver
Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer	NCT00012103	Lung Cancer	bronchoalveolar... screening quest... sputum cytology bronchoscopic a... bronchoscopy computed tomogr... study of high r...	18 Years -	NYU Langone Health
Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer	NCT00894127	Lung Cancer	CyPath	18 Years -	Biomoda Inc.
Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer	NCT00012103	Lung Cancer	bronchoalveolar... screening quest... sputum cytology bronchoscopic a... bronchoscopy computed tomogr... study of high r...	18 Years -	NYU Langone Health
Fluorescent Light Bronchoscopy Plus White Light Bronchoscopy for Early Detection of Lung Cancer	NCT00019201	Head and Neck C... Lung Cancer	cytology specim... immunohistochem... sputum cytology bronchoscopic a... bronchoscopy comparison of s... endoscopic biop...	18 Years -	National Cancer Institute (NCI)
Fluorescent Light Bronchoscopy Plus White Light Bronchoscopy for Early Detection of Lung Cancer	NCT00019201	Head and Neck C... Lung Cancer	cytology specim... immunohistochem... sputum cytology bronchoscopic a... bronchoscopy comparison of s... endoscopic biop...	18 Years -	National Cancer Institute (NCI)
Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers	NCT00899262	Lung Cancer Tobacco Use Dis...	immunohistochem... laboratory biom... sputum cytology Fourier transfo... diagnostic bron...	-	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for sputum cytology