Lung CancerNCT00898313
Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer
An observational study of Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- comparative genomic hybridization, gene expression microarray analysis and proteomic profiling analysis
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2003to 31 Jan 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who may have lung cancer.
Who may be able to join
- -All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.
Who cannot join
- Inability to provide informed consent
- Minors
- Pregnant women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vanderbilt Ingram Clinical Trials Information Program contact
United States2 sites, 2 recruiting
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
VICC Clinical Trials Information Program, 800-811-8480, cip@vanderbilt.edu
Pierre Massion, MD
- Recruiting
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
Research Office, 615-873-8066
Rena Burns, RN, (615) 873-7658, Rena.Burns@va.gov
About this study
Official title: Molecular Predictors of Lung Cancer Behavior
RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.
Read the detailed description
OBJECTIVES:
- To use fixed lung tissue for histological evaluation and fresh tissue samples for molecular studies to study DNA, RNA, and protein abnormalities in lung preneoplastic and neoplastic lesions.
- To use proteomic techniques, including matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS), to develop a method of diagnosing and staging both pre-invasive and invasive lesions, using less invasive methods.
OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection.
Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.
- Conditions
- Lung Cancer
- Being tested
- comparative genomic hybridization, gene expression microarray analysis, proteomic profiling analysis, biologic sample preservation procedure, nasal brushing
- Keywords
- lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparative genomic hybridizationGenetic
Collection of sputum, blood, urine, and a small amount of lung tissue.
gene expression microarray analysisGenetic
Collection of sputum, blood, urine, and a small amount of lung tissue.
proteomic profiling analysisGenetic
Collection of sputum, blood, urine, and a small amount of lung tissue.
biologic sample preservation procedureOther
Collection of sputum, blood, urine, and a small amount of lung tissue.
nasal brushingProcedure or surgery
Using a brush, superficial cells are removed from the nose.
Blood drawProcedure or surgery
Venous blood will be collected
Urine collectionProcedure or surgery
Subjects will be asked to provide a urine specimen.
sputum sampleProcedure or surgery
Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up.
fluorescence bronchoscopy with airway biopsyProcedure or surgery
A flexible tube attached to a fluorescent light source will be inserted into the subject's mouth or nose to reach the airway. Samples of the lining of the airway will be taken, as well as bronchial secretions and epithelial cell from brushings of the lining of the airway.
fine needle aspiration of the lungProcedure or surgery
A small needle is inserted into the lung to collect tissue. This procedure will only be performed if the patient's physician orders it.
thoracentesisProcedure or surgery
A small needle is inserted into the patient's lung cavity and a small amount of fluid is collected. This procedure will only be performed if the patient's physician orders it.
| Study group | Role | What they receive |
|---|---|---|
| Sample Collection | Not described Receives: Genetic: comparative genomic hybridization; Genetic: gene expression microarray analysis; Genetic: proteomic profiling analysis; Other: biologic sample preservation procedure; Procedure: nasal brushing; Procedure: Blood draw; Procedure: Urine collection; Procedure: sputum sample; Procedure: fluorescence bronchoscopy with airway biopsy; Procedure: fine needle aspiration of the lung; Procedure: thoracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantitate the molecular changes during lung cancer development
As a part of the study nasal brushing specimens, sputum, blood, urine, and a small amount of other tissue will be collected during standard of care procedures (bronchial epithelial, trans-thoracic fine needle aspiration (FNA) and thoracentesis as part of patient work up.
Clinical diagnosis is the primary goal of the procedure. All the research specimens are collected after the primary goal of the procedure is met.
Measured: After collection of designated samples
Secondary outcomes (1)
Develop a method to diagnose and stage pre-invasive and invasive lesions
Use of proteomic techniques in the laboratory to find a method of diagnosing lung tissue as benign or malignant rather than relying on invasive open-chest surgery for a diagnosis
Measured: After collection of designated samples
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 startDec 2003
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Fabien Maldonado, Vanderbilt-Ingram Cancer Center
- Investigators
- Fabien Maldonado, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898313
- Sponsor's protocol ID
- VICC THO 0398
- Other IDs
- P30CA068485
- Status last verified
- Apr 2026
- First submitted
- 9 May 2009
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Predictors of Lung Cancer Behavior
- ClinicalTrials.gov ID
- NCT00898313
- Acronym / sponsor ID
- VICC THO 0398
- Conditions
- Lung Cancer
- Keywords
- lung cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2003
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (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: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.
Detailed description
OBJECTIVES:
- To use fixed lung tissue for histological evaluation and fresh tissue samples for molecular studies to study DNA, RNA, and protein abnormalities in lung preneoplastic and neoplastic lesions.
- To use proteomic techniques, including matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS), to develop a method of diagnosing and staging both pre-invasive and invasive lesions, using less invasive methods.
OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection.
Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample Collection | – | Genetic: comparative genomic hybridization, Genetic: gene expression microarray analysis, Genetic: proteomic profiling analysis, Other: biologic sample preservation procedure, Procedure: nasal brushing, Procedure: Blood draw, Procedure: Urine collection, Procedure: sputum sample, Procedure: fluorescence bronchoscopy with airway biopsy, Procedure: fine needle aspiration of the lung, Procedure: thoracentesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who may have lung cancer.
Key inclusion criteria (1 listed)
- -All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Minors
- Pregnant women
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 hybridizationCollection of sputum, blood, urine, and a small amount of lung tissue. | Genetic | Sample Collection |
| gene expression microarray analysisCollection of sputum, blood, urine, and a small amount of lung tissue. | Genetic | Sample Collection |
| proteomic profiling analysisCollection of sputum, blood, urine, and a small amount of lung tissue. | Genetic | Sample Collection |
| biologic sample preservation procedureCollection of sputum, blood, urine, and a small amount of lung tissue. | Other | Sample Collection |
| nasal brushingUsing a brush, superficial cells are removed from the nose. | Procedure or surgery | Sample Collection |
| Blood drawVenous blood will be collected | Procedure or surgery | Sample Collection |
| Urine collectionSubjects will be asked to provide a urine specimen. | Procedure or surgery | Sample Collection |
| sputum samplePrior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up. | Procedure or surgery | Sample Collection |
| fluorescence bronchoscopy with airway biopsyA flexible tube attached to a fluorescent light source will be inserted into the subject's mouth or nose to reach the airway. Samples of the lining of the airway will be taken, as well as bronchial secretions and epithelial cell from brushings of the lining of the airway. | Procedure or surgery | Sample Collection |
| fine needle aspiration of the lungA small needle is inserted into the lung to collect tissue. This procedure will only be performed if the patient's physician orders it. | Procedure or surgery | Sample Collection |
| thoracentesisA small needle is inserted into the patient's lung cavity and a small amount of fluid is collected. This procedure will only be performed if the patient's physician orders it. | Procedure or surgery | Sample Collection |
Primary outcome
To quantitate the molecular changes during lung cancer development
Time frame: After collection of designated samples
As a part of the study nasal brushing specimens, sputum, blood, urine, and a small amount of other tissue will be collected during standard of care procedures (bronchial epithelial, trans-thoracic fine needle aspiration (FNA) and thoracentesis as part of patient work up. Clinical diagnosis is the primary goal of the procedure. All the research specimens are collected after the primary goal of the procedure is met.
1 secondary outcome
Develop a method to diagnose and stage pre-invasive and invasive lesions
Time frame: After collection of designated samples
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 27 Apr 2026.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
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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.
Vanderbilt Ingram Clinical Trials Information Program contact
Fabien Maldonado, MD study chair
Vanderbilt-Ingram Cancer Center
2 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-Ingram Cancer Center at 2 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?
The sponsor lists 1 inclusion and 3 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 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 Vanderbilt Ingram Clinical Trials Information Program (1-800-811-8480), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To quantitate the molecular changes during lung cancer development (time frame: After collection of designated samples). 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 27 Apr 2026.