Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With 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):
William Pao, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00897650
First received: May 9, 2009
Last updated: April 2, 2013
Last verified: February 2013
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Purpose
RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in RNA and identify protein expression patterns related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at protein and RNA expression patterns in predicting response to treatment in patients with lung cancer.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Genetic: RNA microarray analysis Genetic: Protein expression analysis Procedure: Lung tumor biopsy Procedure: Blood sample |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Molecular Fingerprints in Lung Cancer: Predicting Tumor Response to Therapy |
Resource links provided by NLM:
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- Protein and/or RNA expression patterns [ Time Frame: After lung tumor tissue and blood collection. ] [ Designated as safety issue: No ]Protein and/or RNA expression patterns in lung tumor tissue that are capable of predicting tumor response to therapy
Secondary Outcome Measures:
- Characterization of genes and proteins predictive of response to therapy [ Time Frame: After lung tumor tissue and blood collection ] [ Designated as safety issue: No ]Identify genes and proteins predictive of response to therapy and that can be used to identify novel mechanisms underlying lung cancer behavior
Biospecimen Retention: Samples With DNA
Lung tumor tissue and blood samples will be collected.
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2005 |
| Estimated Primary Completion Date: | December 2019 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Lung cancer
Patients with a diagnosis of invasive lung cancer.
|
Genetic: RNA microarray analysis
Lung tumor tissue will be collected.
Genetic: Protein expression analysis
Lung tumor tissue will be collected.
Other Name: Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI)
Procedure: Lung tumor biopsy
Tissue will be collected by percutaneous fine needle aspiration, a percutaneous core biopsy, or during a medically indicated procedure during which lung tumor tissue will be removed
Procedure: Blood sample
Patients will be asked for a venous blood sample
|
Detailed Description:
OBJECTIVES:
- To determine protein and/or RNA expression patterns capable of predicting tumor response to therapy in tumor tissue samples from patients with lung cancer or suspected of having lung cancer.
- To characterize the genes and proteins found to be predictive of response in order to help elucidate the molecular biology underlying cancer chemosensitivity.
OUTLINE: Patients undergo collection of tumor tissue by percutaneous fine needle aspiration, core biopsy, or during any medically indicated procedure involving removal of lung tissue. Tissue samples are analyzed by Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-MS) and RNA microarrays for protein and gene expression patterns and for identification of genes and proteins predictive of treatment response. Blood samples are also collected to obtain normal DNA for analysis.
After completion of study, patients will be followed until their death.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
People who have or may have lung cancer.
Criteria
Inclusion criteria
- Diagnosis of suspected lung cancer or lung cancer
Exclusion criteria
- Inability to undergo therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897650
Contacts
| Contact: VICC Clinical Trial Information Program | 800-811-8480 |
Locations
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: VICC Clinical Trials Information Program 800-811-8480 | |
| Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: VICC 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 | |
| Principal Investigator: William Pao, MD | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Study Chair: | William Pao, MD | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | William Pao, MD, Professor of Medicine, Cancer Biology, & Pathology/ Microbiology/ Immunology, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00897650 History of Changes |
| Other Study ID Numbers: | VICC THO 0547, P30CA068485, VU-VICC-THO-0547, P50CA090949 |
| Study First Received: | May 9, 2009 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Vanderbilt University Human Research Protection Program |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013