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Trial Title:
Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease
NCT ID:
NCT01450553
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Tissue Collection
Lung Cancer
Non-Small Cell Lung Cancer
Early Stage Lung Cancer
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Detailed description:
Patients with early stage NSCLC will be consented prior to surgery so that any excess
tissue collected during surgery can be collected in one of the three tissue formats
(Fresh Frozen, FFPE, RNAlater) and sent to the Sponsor for testing.
Criteria for eligibility:
Study pop:
Non-Small Cell Lung Cancer patients undergoing surgery for resection of disease from
hospital based locations.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cardio-Thoracic Surgeons, P. C.
Address:
City:
Birmingham
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Alabama at Birmingham
Address:
City:
Birmingham
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Martin Memorial Treasure Coast Surgeons
Address:
City:
Stuart
Country:
United States
Status:
Recruiting
Facility:
Name:
Baptist Hospital East
Address:
City:
Louisville
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pittsburgh Medical Center
Address:
City:
Pittsburgh
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Centennial Thoraic Surgeons
Address:
City:
Nashville
Country:
United States
Status:
Recruiting
Start date:
October 2011
Lead sponsor:
Agency:
Precision Therapeutics
Agency class:
Industry
Source:
Precision Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01450553
