Lung CancerNCT00899028
Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants
An observational study of Lung Cancer, run by Vanderbilt University Medical Center at 4 sites in United States.
Trial summary
RATIONALE: Studying samples of tissue, blood, sputum, and urine from patients with lung cancer and from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- comparative genomic hybridization, fluorescence in situ hybridization and gene expression analysis
- Type of treatment
- Surgery or procedure
- How many people
- 689 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2001to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Known or previously diagnosed lung cancer
- Suspected lung cancer, including the following:
- Completely resected stage I lung cancer (with no evidence of metastatic disease) for which patient is at risk for developing secondary disease
- Suspected of having lung cancer due to clinical symptoms, such as positive sputum cytology, hemoptysis, unresolved pneumonia, persistent cough, and positive x-ray
- Healthy volunteer
PATIENT CHARACTERISTICS:
- WBC ≥ 2,000/mm³ but ≤ 20,000/mm³
- Platelet count ≥ 50,000/mm³
- Not pregnant
- No uncontrolled hypertension (i.e., systolic blood pressure > 200 mm Hg, diastolic blood pressure > 120 mm Hg)
- No unstable angina
- No known bleeding disorder
- No other contraindications for white light bronchoscopic examination
- No other contraindications for fluorescence examination
PRIOR CONCURRENT THERAPY:
- More than 3 months since prior fluorescent photosensitizing agents (hematoporphyrin derivatives)
- More than 3 months since prior and no concurrent chemopreventative drugs (e.g., tretinoin)
- More than 6 months since prior ionizing radiation treatment to the chest
- More than 6 months since prior systemic cytotoxic chemotherapy
- No concurrent anticoagulant therapy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Identification and Validation of Molecular Markers in Lung Cancer
RATIONALE: Studying samples of tissue, blood, sputum, and urine from patients with lung cancer and from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at biomarkers for lung cancer using tissue samples from patients with lung cancer and from healthy participants.
Read the detailed description
OBJECTIVES:
- To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.
- To determine the prevalence of candidate biomarkers in lung cancer progression.
- To determine the odds of developing lung cancer according to biomarker status in preinvasive lesions.
- To determine the odds of developing lung cancer according to proteomic biomarker status in the normal bronchial epithelium of high-risk patients.
OUTLINE: This is a multicenter study.
Tissue samples are collected at the time of fluorescence bronchoscopy for laboratory biomarker studies. Blood, sputum, and urine samples are also collected. Gene and protein expression studies are performed on the samples using comparative genomic hybridization array, 3q oligonucleotide microarray, matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF), fluorescence in situ hybridization (FISH), and immunohistochemistry (IHC).
Patients' medical records are reviewed to collect information about the patient's past medical history and pertinent laboratory and radiography results.
Patients and healthy volunteers are followed annually via telephone or a mailed questionnaire.
- Conditions
- Lung Cancer
- Being tested
- comparative genomic hybridization, fluorescence in situ hybridization, gene expression analysis, microarray analysis, protein expression analysis
- Keywords
- stage 0 non-small cell lung cancer, stage I non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, stage II non-small cell lung cancer, stage IV non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparative genomic hybridizationGenetic
fluorescence in situ hybridizationGenetic
gene expression analysisGenetic
microarray analysisGenetic
protein expression analysisGenetic
laboratory biomarker analysisOther
matrix-assisted laser desorption/ionization time of flight mass spectrometryOther
medical chart reviewOther
diagnostic bronchoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of new molecular markers specific to the development of squamous cell lung cancer
Prevalence of candidate biomarkers in lung cancer progression
Odds of developing lung cancer according to biomarker status
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 startMay 2001
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Enrolment
- 689 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Pierre P. Massion, Vanderbilt University Medical Center
- Investigators
- Pierre P. Massion, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899028
- Sponsor's protocol ID
- CDR0000584223
- Other IDs
- R01CA102353, P30CA068485, VU-VICC-THO-0373, VU-VICC-010178
- Status last verified
- Apr 2017
- First submitted
- 9 May 2009
- Last updated
- 20 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Validation of Molecular Markers in Lung Cancer
- ClinicalTrials.gov ID
- NCT00899028
- Acronym / sponsor ID
- CDR0000584223
- Conditions
- Lung Cancer
- Keywords
- stage 0 non-small cell lung cancer, stage I non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, stage II non-small cell lung cancer, stage IV non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 689 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2001
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- 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 tissue, blood, sputum, and urine from patients with lung cancer and from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at biomarkers for lung cancer using tissue samples from patients with lung cancer and from healthy participants.
Detailed description
OBJECTIVES:
- To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.
- To determine the prevalence of candidate biomarkers in lung cancer progression.
- To determine the odds of developing lung cancer according to biomarker status in preinvasive lesions.
- To determine the odds of developing lung cancer according to proteomic biomarker status in the normal bronchial epithelium of high-risk patients.
OUTLINE: This is a multicenter study.
Tissue samples are collected at the time of fluorescence bronchoscopy for laboratory biomarker studies. Blood, sputum, and urine samples are also collected. Gene and protein expression studies are performed on the samples using comparative genomic hybridization array, 3q oligonucleotide microarray, matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF), fluorescence in situ hybridization (FISH), and immunohistochemistry (IHC).
Patients' medical records are reviewed to collect information about the patient's past medical history and pertinent laboratory and radiography results.
Patients and healthy volunteers are followed annually via telephone or a mailed questionnaire.
Study design
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| comparative genomic hybridization | Genetic | – |
| fluorescence in situ hybridization | Genetic | – |
| gene expression analysis | Genetic | – |
| microarray analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| matrix-assisted laser desorption/ionization time of flight mass spectrometry | Other | – |
| medical chart review | Other | – |
| diagnostic bronchoscopy | Procedure or surgery | – |
Primary outcome
Identification of new molecular markers specific to the development of squamous cell lung cancer
Prevalence of candidate biomarkers in lung cancer progression
Odds of developing lung cancer according to biomarker status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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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. This study is not recruiting at the moment.
Pierre P. Massion, MD study chair
Vanderbilt-Ingram Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Vanderbilt University Medical Center at 4 sites 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?
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: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of new molecular markers specific to the development of squamous cell lung cancer. The study lists 3 primary outcomes in all. 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 20 Apr 2017.