NCT00019201

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 29, 2015

Status Verified

February 1, 2000

First QC Date

July 11, 2001

Last Update Submit

April 28, 2015

Conditions

Head and Neck CancerLung Cancer

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancerstage III non-small cell lung cancerlimited stage small cell lung cancerstage I nasopharyngeal cancerstage II nasopharyngeal cancerstage III nasopharyngeal cancerstage I lip and oral cavity cancerstage II lip and oral cavity cancerstage III lip and oral cavity cancerstage I hypopharyngeal cancerstage II hypopharyngeal cancerstage III hypopharyngeal cancerstage I laryngeal cancerstage II laryngeal cancerstage III laryngeal cancerstage I paranasal sinus and nasal cavity cancerstage II paranasal sinus and nasal cavity cancerstage III paranasal sinus and nasal cavity cancerstage I oropharyngeal cancerstage II oropharyngeal cancerstage III oropharyngeal cancer

Interventions

cytology specimen collection procedureOTHER
immunohistochemistry staining methodOTHER
sputum cytologyOTHER
bronchoscopic and lung imaging studiesPROCEDURE
bronchoscopyPROCEDURE
comparison of screening methodsPROCEDURE
endoscopic biopsyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * The following diagnoses are eligible: * Known or suspected bronchogenic carcinoma scheduled for bronchoscopy as part of standard diagnostic or staging work-up * Completely resected stage I/II non-small cell lung cancer with no evidence of metastasis * Stage III non-small cell lung cancer with no evidence of disease for at least 2 years following treatment * Small cell lung cancer with no evidence of disease for at least 2 years following treatment * Completely resected head and neck cancer with no evidence of metastasis * Ability to produce sputum samples required PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Hematopoietic: * WBC 2,000-20,000 * Platelets at least 50,000 Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No uncontrolled hypertension (i.e., systolic pressure greater than 200 mm Hg or diastolic pressure greater than 120 mm Hg) * No unstable angina Other: * No bleeding disorder * No allergic reaction to topical lidocaine * No pregnant women PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * At least 18 months since ionizing radiotherapy to the chest Surgery * See Disease Characteristics Other * At least 1 month since yttrium-aluminum-garnet (YAG) laser therapy to the lung * At least 3 months since fluorescent photosensitizing drugs (e.g., Photofrin)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsLung NeoplasmsCarcinoma, Non-Small-Cell LungNasopharyngeal NeoplasmsMouth NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsOropharyngeal Neoplasms

Interventions

ImmunohistochemistryBronchoscopyEndoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth DiseasesLaryngeal Diseases

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic TechniquesDiagnostic Techniques, Respiratory SystemEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical ProceduresEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDigestive System Surgical Procedures

Study Officials

  • J. Michael Hamilton, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SCREENING
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

August 1, 1996

Last Updated

April 29, 2015

Record last verified: 2000-02

Locations

US(1)