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Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer

Molecular Fingerprinting of Lung Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00897117
Enrollment
4000
Registered
2009-05-12
Start date
2001-05-31
Completion date
2031-05-31
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer, stage II non-small cell lung cancer

Brief 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. 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.

Interventions

GENETICgene expression analysis

Blood and lung tissue collection

GENETICmicroarray analysis

Blood and lung tissue collection

GENETICprotein expression analysis

Blood and lung tissue collection

OTHERbiologic sample preservation procedure

Blood and lung tissue collection

OTHERlaboratory biomarker analysis

Blood and lung tissue collection

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt-Ingram Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Chemotherapy before surgery * Radiotherapy before surgery

Design outcomes

Primary

MeasureTime frame
Protein and RNA expression fingerprints from collected samplesafter collection of designated samples

Secondary

MeasureTime frame
Development of statistical and computational methods to model relationship of data and clinical outcomesafter laboratory gene analysis work is completed
Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survivalafter collection of designated samples

Countries

United States

Contacts

Primary ContactVICC Clinical Trials Information Program
cip@vumc.org800-811-8480

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026