Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease
Research and Development Study: Tissue Collection From Patients Who Are Undergoing Surgery for Non-Small Cell Lung Cancer
1 other identifier
observational
450
1 country
7
Brief Summary
A 15-gene lung signature was created to identify predictive and prognostic biomarkers for Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk and low risk cohorts with significantly different survivals. Using fresh frozen tissue can be challenging, so this study attempts simplify the process by migrating the 15-gene signature from fresh frozen to two alternative tissue formats: Formalin Fixed Paraffin Embedded (FFPE) and RNAlater. The gene expressions of the different tissue formats will be compared to see if the fresh frozen tissue results are similar to the alternative tissue formats.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 7, 2011
CompletedFirst Posted
Study publicly available on registry
October 12, 2011
CompletedJanuary 11, 2012
January 1, 2012
October 7, 2011
January 9, 2012
Conditions
Keywords
Eligibility Criteria
Non-Small Cell Lung Cancer patients undergoing surgery for resection of disease from hospital based locations.
You may qualify if:
- New diagnosis of stage I or II Non-Small Cell Lung Cancer (NSCLC)
- Must have resectable disease and complete surgical resection planned
- Histologically or cytologically confirmed adenocarcinoma, squamous or large cell carcinoma NSCLC
- No prior chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer
- Tumor specimen samples must be collected within 1 hour of surgery
- Patient must be at least 18 years of age
- Patient must sign and date an approved study consent form
You may not qualify if:
- Patients with psychiatric or addictive disorders that would preclude obtaining study consent
- Informed consent obtained the same day as surgery
- Absence of histological diagnosis of lung cancer
- Known infectious disease
- History of chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer or any prior cancer or any other non-cancer diseases or illnesses, i.e. rheumatoid arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Cardio-Thoracic Surgeons, P. C.
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Martin Memorial Treasure Coast Surgeons
Stuart, Florida, United States
Baptist Hospital East
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Centennial Thoraic Surgeons
Nashville, Tennessee, United States
Biospecimen
Human tumor tissues will be collected and preserved in three different tissue formats: * Fresh Frozen * FFPE * RNAlater
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2011
First Posted
October 12, 2011
Study Start
October 1, 2011
Last Updated
January 11, 2012
Record last verified: 2012-01