Esophageal CancerNCT00900419
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
An observational study of Esophageal Cancer and Head and Neck Cancer, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Esophageal Cancer, Head and Neck Cancer, Lung Cancer
- What is being tested?
- immunohistochemistry staining method, laboratory biomarker analysis and sputum cytology
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2001to 30 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High Risk for Lung Cancer, suspected lung cancer, lung cancer.
Who may be able to join
- Two broad patient groups are of interest: those with extensive and severe dysplasia of the respiratory epithelium and those without dysplasia of the respiratory epithelium. The patients with dysplasia will be recruited from the following:
- Individuals identified through the SPORE Tissue Procurement Screening Project with moderate or severe dysplasia.
- Patients identified by private and academic physicians with moderate or severe dysplasia on cytology.
- One year or greater survivors of one or more aerodigestive system carcinomas.
- Patients with head and neck cancers who are undergoing routine panendoscopy.
- Patients undergoing resection of a bronchogenic carcinoma.
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- Fully resected Stage I non-small cell cancer patients.
- Patient's undergoing bronchoscopy for diagnosis or staging of suspected lung cancer.
- Subjects with previous high-grade dysplasia or worse undergoing subsequent bronchoscopy for surveillance or monitoring of response to endobronchial treatment.
- 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.
Who cannot join
- Patients are not eligible if any one of the following conditions exist:
- Clinically apparent bleeding diathesis.
- Cardiac dysrhythmia that is potentially life threatening, such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or rare (< 2/minute) premature ventricular contractions are not exclusionary.
- Hypoxemia (less than 90% saturation with supplemental oxygen) prior to bronchoscopy.
- Evidence of clinically active coronary artery disease, including myocardial infarction within 6 weeks, anginal chest pain, or poorly controlled congestive heart failure, or any other serious medical condition which would preclude a patient from undergoing a bronchoscopy.
- Acute bronchitis or pneumonia within 8 weeks, except if these are considered clinically to be possibly a result of lung cancer.
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045
Clinical Trials Office - University of Colorado Cancer Center, 303-724-1657
About this study
Official title: Biomarkers and Dysplastic Respiratory Epithelium
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.
Read the detailed 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.
- Being tested
- immunohistochemistry staining method, laboratory biomarker analysis, sputum cytology, biopsy
- 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
- Medical subject headings
- Esophageal Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Precancerous Conditions, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Hypopharyngeal Neoplasms, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemistry staining methodOther
Laboratory test
laboratory biomarker analysisOther
Laboratory Test
sputum cytologyOther
Laboratory Test
biopsyProcedure or surgery
Laboratory Test
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic mutations or altered growth factor expression
Measured: After study has completed
Secondary outcomes (1)
Establishment of a tissue repository of normal and dysplastic respiratory epithelium
Measured: After study has closed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start3 May 2001
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert L. Keith, MD, Principal investigator, University of Colorado Cancer Center, Anschutz Medical Campus; Rocky Mountain Regional VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900419
- Sponsor's protocol ID
- 00-1108.cc
- Other IDs
- SPORE 24, P50CA058187
- Status last verified
- Oct 2026
- First submitted
- 9 May 2009
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Dysplastic Respiratory Epithelium
- ClinicalTrials.gov ID
- NCT00900419
- Acronym / sponsor ID
- 00-1108.cc
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 May 2001 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High Risk for Lung Cancer, suspected lung cancer, lung cancer.
Key inclusion criteria (11 listed)
- Two broad patient groups are of interest: those with extensive and severe dysplasia of the respiratory epithelium and those without dysplasia of the respiratory epithelium. The patients with dysplasia will be recruited from the following:
- Individuals identified through the SPORE Tissue Procurement Screening Project with moderate or severe dysplasia.
- Patients identified by private and academic physicians with moderate or severe dysplasia on cytology.
- One year or greater survivors of one or more aerodigestive system carcinomas.
- Patients with head and neck cancers who are undergoing routine panendoscopy.
Key exclusion criteria (7 listed)
- Clinically apparent bleeding diathesis.
- Cardiac dysrhythmia that is potentially life threatening, such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or rare (< 2/minute) premature ventricular contractions are not exclusionary.
- Hypoxemia (less than 90% saturation with supplemental oxygen) prior to bronchoscopy.
- Evidence of clinically active coronary artery disease, including myocardial infarction within 6 weeks, anginal chest pain, or poorly controlled congestive heart failure, or any other serious medical condition which would preclude a patient from undergoing a bronchoscopy.
- Acute bronchitis or pneumonia within 8 weeks, except if these are considered clinically to be possibly a result of lung cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunohistochemistry staining methodLaboratory test | Other | – |
| laboratory biomarker analysisLaboratory Test | Other | – |
| sputum cytologyLaboratory Test | Other | – |
| biopsyLaboratory Test | Procedure or surgery | – |
Primary outcome
Genetic mutations or altered growth factor expression
Time frame: After study has completed
1 secondary outcome
Establishment of a tissue repository of normal and dysplastic respiratory epithelium
Time frame: After study has closed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert L. Keith, MD principal investigator
University of Colorado Cancer Center, Anschutz Medical Campus; Rocky Mountain Regional VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Head and Neck Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandi Kubala, MA, CCRP (303-724-1657, brandi.kubala@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic mutations or altered growth factor expression (time frame: After study has completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.