Lung CancerNCT00897117
Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer
An observational study of Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in RNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- gene expression analysis, microarray analysis and protein expression analysis
- How many people
- 4,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2001to 31 May 2031
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who have clinical stage I and II non-small cell lung cancer
Who may be able to join
- Diagnosis of non-small cell lung cancer
- Clinical stage I and II disease
- Resectable disease and complete surgical resection planned
- Treated on companion studies at Vanderbilt University, the Veterans Administration hospital, St. Thomas, and Vanderbilt-Ingram Cancer Center Affiliate Network
- Tumor specimen samples must be available at resection
Who cannot join
- Chemotherapy before surgery
- Radiotherapy before surgery
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Completed
Dan Rudy Cancer Center at Saint Thomas Hospital
Nashville, Tennessee, 37205
- Suspended
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Clinical Trials Office - Vanderbilt-Ingram Cancer Center, 800-811-8480
About this study
Official title: Molecular Fingerprinting of Lung Cancer
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in RNA and identify biomarkers related to cancer.
PURPOSE: This research study is collecting and analyzing lung tissue samples from patients undergoing surgery for non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Develop statistical and computational methods for modeling the relationships between multiple variable protein and RNA expression data and clinical endpoints using both supervised and unsupervised classification and pattern recognition approaches.
- Determine protein and RNA expression fingerprints on completely resected non-small cell lung cancer without prior chemotherapy.
- Correlate protein and RNA expression fingerprints with T-stage and nodal involvement at the time of surgery, and collect outcome data to allow correlation with recurrence (local and/or distant) and survival.
OUTLINE: This is a multicenter study.
Any excess tissues removed from surgery and would otherwise be discarded (tissues not used for diagnosis and/or treatment decision making) are obtained for this study. Tissue are analyzed for molecular features that predict biologic behavior. Quantitation of RNA, gene expression profiles, and protein expression patterns are assessed by matrix-assisted laser desorption/ionization time of flight mass spectroscopy and microarray analysis.
Medical records are reviewed to obtain information about results of tests associated with cancer diagnosis. Further progress in cancer treatment and tumor behavior after surgery are followed via record review.
- Conditions
- Lung Cancer
- Being tested
- gene expression analysis, microarray analysis, protein expression analysis, biologic sample preservation procedure, laboratory biomarker analysis
- Keywords
- stage I non-small cell lung cancer, stage II 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.
gene expression analysisGenetic
Blood and lung tissue collection
microarray analysisGenetic
Blood and lung tissue collection
protein expression analysisGenetic
Blood and lung tissue collection
biologic sample preservation procedureOther
Blood and lung tissue collection
laboratory biomarker analysisOther
Blood and lung tissue collection
matrix-assisted laser desorption/ionization time of flight mass spectrometryOther
Blood and lung tissue collection
| Study group | Role | What they receive |
|---|---|---|
| Resectable non-small cell lung cancer | Patients with clinical stage I or II invasive lung cancer that can be completely removed by surgery and who have not undergone chemotherapy or radiotherapy before surgery Receives: Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: protein expression analysis; Other: biologic sample preservation procedure; Other: laboratory biomarker analysis; Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein and RNA expression fingerprints from collected samples
Measured: after collection of designated samples
Secondary outcomes (2)
Development of statistical and computational methods to model relationship of data and clinical outcomes
Measured: after laboratory gene analysis work is completed
Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival
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 start1 May 2001
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2031 (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, Eric Grogan, Vanderbilt-Ingram Cancer Center
- Investigators
- Eric Grogan, MD, Principal investigator, Vanderbilt Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897117
- Sponsor's protocol ID
- VICC THO 0136
- Other IDs
- P50CA090949, VU-VICC-THO-0136, P30CA068485
- Status last verified
- Aug 2026
- First submitted
- 9 May 2009
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Fingerprinting of Lung Cancer
- ClinicalTrials.gov ID
- NCT00897117
- Acronym / sponsor ID
- VICC THO 0136
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell 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
- 1 May 2001 (actual)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2031 (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 tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in RNA and identify biomarkers related to cancer.
PURPOSE: This research study is collecting and analyzing lung tissue samples from patients undergoing surgery for non-small cell lung cancer.
Detailed description
OBJECTIVES:
- Develop statistical and computational methods for modeling the relationships between multiple variable protein and RNA expression data and clinical endpoints using both supervised and unsupervised classification and pattern recognition approaches.
- Determine protein and RNA expression fingerprints on completely resected non-small cell lung cancer without prior chemotherapy.
- Correlate protein and RNA expression fingerprints with T-stage and nodal involvement at the time of surgery, and collect outcome data to allow correlation with recurrence (local and/or distant) and survival.
OUTLINE: This is a multicenter study.
Any excess tissues removed from surgery and would otherwise be discarded (tissues not used for diagnosis and/or treatment decision making) are obtained for this study. Tissue are analyzed for molecular features that predict biologic behavior. Quantitation of RNA, gene expression profiles, and protein expression patterns are assessed by matrix-assisted laser desorption/ionization time of flight mass spectroscopy and microarray analysis.
Medical records are reviewed to obtain information about results of tests associated with cancer diagnosis. Further progress in cancer treatment and tumor behavior after surgery are followed via record review.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resectable non-small cell lung cancer | – | Genetic: gene expression analysis, Genetic: microarray analysis, Genetic: protein expression analysis, Other: biologic sample preservation procedure, Other: laboratory biomarker analysis, Other: matrix-assisted laser desorption/ionization time of flight mass spectrometryPatients with clinical stage I or II invasive lung cancer that can be completely removed by surgery and who have not undergone chemotherapy or radiotherapy before surgery |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have clinical stage I and II non-small cell lung cancer
Key inclusion criteria (5 listed)
- Diagnosis of non-small cell lung cancer
- Treated on companion studies at Vanderbilt University, the Veterans Administration hospital, St. Thomas, and Vanderbilt-Ingram Cancer Center Affiliate Network
- Tumor specimen samples must be available at resection
Key exclusion criteria (2 listed)
- Chemotherapy before surgery
- Radiotherapy before surgery
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 |
|---|---|---|
| gene expression analysisBlood and lung tissue collection | Genetic | Resectable non-small cell lung cancer |
| microarray analysisBlood and lung tissue collection | Genetic | Resectable non-small cell lung cancer |
| protein expression analysisBlood and lung tissue collection | Genetic | Resectable non-small cell lung cancer |
| biologic sample preservation procedureBlood and lung tissue collection | Other | Resectable non-small cell lung cancer |
| laboratory biomarker analysisBlood and lung tissue collection | Other | Resectable non-small cell lung cancer |
| matrix-assisted laser desorption/ionization time of flight mass spectrometryBlood and lung tissue collection | Other | Resectable non-small cell lung cancer |
Primary outcome
Protein and RNA expression fingerprints from collected samples
Time frame: after collection of designated samples
2 secondary outcomes
Development of statistical and computational methods to model relationship of data and clinical outcomes
Time frame: after laboratory gene analysis work is completed
Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival
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 20 Aug 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.
Eric Grogan, MD principal investigator
Vanderbilt Medical Center
3 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 3 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 5 inclusion and 2 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 VICC Clinical Trials Information Program (800-811-8480, cip@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein and RNA expression fingerprints from collected samples (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 20 Aug 2026.