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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00900419
First received: May 9, 2009
Last updated: May 5, 2014
Last verified: May 2014

May 9, 2009
May 5, 2014
March 2002
May 2015   (final data collection date for primary outcome measure)
Genetic mutations or altered growth factor expression [ Time Frame: After study has completed ] [ Designated as safety issue: No ]
Genetic mutations or altered growth factor expression [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00900419 on ClinicalTrials.gov Archive Site
Establishment of a tissue repository of normal and dysplastic respiratory epithelium [ Time Frame: After study has closed ] [ Designated as safety issue: No ]
Establishment of a tissue repository of normal and dysplastic respiratory epithelium [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with dysplasia or cancer and from normal volunteers 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 and in normal volunteers.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Sputum sample,Endobronchial biopsy, bronchial secretions, pulmonary labage, blood and urine, buccal smears,exhaled breath collection.

Non-Probability Sample

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

  • Esophageal Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Precancerous Condition
  • Other: immunohistochemistry staining method
    Laboratory test
  • Other: laboratory biomarker analysis
    Laboratory Test
  • Other: sputum cytology
    Laboratory Test
  • Procedure: biopsy
    Laboratory Test
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
May 2015
May 2015   (final data collection date for primary outcome measure)

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 dysplasia (normal volunteers)

      • 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
Both
21 Years to 90 Years
Yes
United States
 
NCT00900419
00-1108, SPORE 24, P50CA058187
No
University of Colorado, Denver
University of Colorado, Denver
National Cancer Institute (NCI)
Principal Investigator: York E. Miller, MD University of Colorado, Denver
University of Colorado, Denver
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP