Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified February 2013 by Vanderbilt-Ingram Cancer Center
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by (Responsible Party):
Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00897117
First received: May 9, 2009
Last updated: February 22, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
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 spectrometry |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Molecular Fingerprinting of Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- Protein and RNA expression fingerprints from collected samples [ Time Frame: after collection of designated samples ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Development of statistical and computational methods to model relationship of data and clinical outcomes [ Time Frame: after laboratory gene analysis work is completed ] [ Designated as safety issue: No ]
- Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival [ Time Frame: after collection of designated samples ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Both prospective and retrospectives samples of blood and tissue.
| Estimated Enrollment: | 1200 |
| Study Start Date: | May 2001 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Genetic: gene expression analysis
Blood and lung tissue collection
Genetic: microarray analysis
Blood and lung tissue collection
Genetic: protein expression analysis
Blood and lung tissue collection
Other: biologic sample preservation procedure
Blood and lung tissue collection
Other: laboratory biomarker analysis
Blood and lung tissue collection
Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry
Blood and lung tissue collection
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
People who have clinical stage I and II non-small cell lung cancer
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897117
Contacts
| Contact: VICC Clinical Trials Information Program | 800-811-8480 |
Locations
| United States, Tennessee | |
| Dan Rudy Cancer Center at Saint Thomas Hospital | Recruiting |
| Nashville, Tennessee, United States, 37205 | |
| Contact: Contact Person 615-222-2166 | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Clinical Trials Information Program 800-811-8480 | |
| Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Clinical Trials Information Program 800-811-8480 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| Veterans Affairs Medical Center - Nashville | Recruiting |
| Nashville, Tennessee, United States, 37212 | |
| Contact: Clinical Trials Office - Veterans Affairs Medical Center - Nas 615-327-4751 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Principal Investigator: | Pierre P. Massion, MD | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pierre P. Massion, MD, Associate Professor of Medicine (Allergy, Pulmonary & Critical Care) and Cancer Biology; Pulmonary and Critical Care Medicine Doctor, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00897117 History of Changes |
| Other Study ID Numbers: | VICC THO 0136, P50CA090949, VU-VICC-THO-0136, P30CA068485 |
| Study First Received: | May 9, 2009 |
| Last Updated: | February 22, 2013 |
| Health Authority: | Unites States: Vanderbilt University Human Research Protection Program |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
stage I non-small cell lung cancer stage II non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 13, 2013