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

NCT00900419 | Recruiting

• 3 other identifiers: 00-1108.ccSPORE 24P50CA058187
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer; Head and Neck Cancer; Lung Cancer; Precancerous Condition

Keywords

non-small cell lung cancer; small cell lung cancer; squamous lung dysplasia; hypopharyngeal cancer; laryngeal cancer; lip and oral cavity cancer; metastatic squamous neck cancer with occult primary; nasopharyngeal cancer; oropharyngeal cancer; paranasal sinus and nasal cavity cancer; salivary gland cancer; esophageal cancer; pulmonary carcinoid tumor; tongue cancer

Outcome Measures

Primary Outcomes (1)

• Genetic mutations or altered growth factor expression

  After study has completed

Secondary Outcomes (1)

• Establishment of a tissue repository of normal and dysplastic respiratory epithelium

  After study has closed

Interventions

immunohistochemistry staining method OTHER

Laboratory test

laboratory biomarker analysis OTHER

Laboratory Test

sputum cytology OTHER

Laboratory Test

biopsy PROCEDURE

Laboratory Test

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High Risk for Lung Cancer, suspected lung cancer, lung cancer.

You may qualify if:

• Diagnosis of extensive and severe dysplasia of the respiratory epithelium
• Those without dysplasia of the respiratory epithelium
• Recruited from the SPORE Tissue Procurement Screening Project or by private or academic physicians (for patients with moderate or severe dysplasia)
• Survived 1 or more aerodigestive system carcinoma for ≥ 1 year
• Completely resected stage I non-small cell cancer
• Undergoing any of the following procedures:
• Routine panendoscopy for patients with head and neck cancer
• Resection of a bronchogenic carcinoma
• Bronchoscopy for diagnosis or staging of suspected lung cancer
• Subsequent bronchoscopy for surveillance or monitoring of response to endobronchial treatment in patients with prior high-grade dysplasia or worse
• No asthma
• No lung disease
• No respiratory illness within the past 2 weeks Patients suspected of or at risk for neoplastic lung disease who are undergoing a bronchoscopy in which differential diagnostic considerations may include multiple other etiologies such as infection and other processes.
• Patients without dysplasia will be: patients undergoing clinically indicated bronchoscopy for conditions other than suspected lung cancer.
• PATIENT CHARACTERISTICS:

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Esophageal Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Precancerous Conditions; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Mouth Neoplasms; Nasopharyngeal Neoplasms; Oropharyngeal Neoplasms; Salivary Gland Neoplasms; Tongue Neoplasms

Interventions

Immunohistochemistry; Biopsy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Mouth Diseases; Nasopharyngeal Diseases; Salivary Gland Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• York E. Miller, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandi Kubala

CONTACT

303-724-1657; brandi.kubala@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: May 3, 2001
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (1)