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

Lung Cancer Clinical Trial

Official title:

Biomarkers and Dysplastic Respiratory Epithelium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00900419
• Other study ID #: 00-1108.cc
• Secondary ID: SPORE 24P50CA058
• Status: Recruiting
• Start date: May 3, 2001
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Brandi Kubala
• Phone: 303-724-1657
• Email: brandi.kubala[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

DISEASE CHARACTERISTICS:

• Meets any of the following criteria:

• Diagnosis of extensive and severe 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.

PATIENT CHARACTERISTICS:

• No clinically apparent bleeding diathesis

• No known bleeding disorder

• No anginal

• No clinically active coronary artery disease

• No multifocal premature ventricular contractions

• No poorly controlled congestive heart failure

• No myocardial infarction within the past 6 weeks

• No cardiac dysrhythmia that is potentially life threatening

• Well-controlled atrial fibrillation or rare (< 2/min) premature ventricular contractions allowed

• No ventricular tachycardia or supraventricular tachycardia with a rapid ventricular response

• No other serious medical condition that would preclude a patient from undergoing a bronchoscopy

• No acute bronchitis or pneumonia within the past 8 weeks except when clinically proven as a possible result of lung cancer

• No hypoxemia (i.e., < 90% saturation with supplemental oxygen) before bronchoscopy

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Lung Neoplasms
• Precancerous Condition
• Precancerous Conditions

Intervention

Other:
• immunohistochemistry staining method
Laboratory test
• laboratory biomarker analysis
Laboratory Test
• sputum cytology
Laboratory Test

Procedure:
• biopsy
Laboratory Test

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic mutations or altered growth factor expression		After study has completed
Secondary	Establishment of a tissue repository of normal and dysplastic respiratory epithelium		After study has closed