Clinical trial NCT00897117: Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer
Official title: Molecular Fingerprinting of Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
stage II non-small cell lung cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People who have clinical stage I and 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.

Eligibility criteria: 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

Primary outcomes:
measure: Protein and RNA expression fingerprints from collected samples
timeFrame: after collection of designated samples
Secondary outcomes:
measure: Development of statistical and computational methods to model relationship of data and clinical outcomes
timeFrame: after laboratory gene analysis work is completed
measure: Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival
timeFrame: after collection of designated samples
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Dan Rudy Cancer Center at Saint Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Veterans Affairs Medical Center - Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt Medical Center
name: Eric Grogan, MD
role: PRINCIPAL_INVESTIGATOR
References: