Clinical trial NCT01450553: Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease
Official title: Research and Development Study: Tissue Collection From Patients Who Are Undergoing Surgery for Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small Cell Lung Cancer
Keywords: Tissue Collection
Lung Cancer
Non-Small Cell Lung Cancer
Early Stage Lung Cancer
Lead sponsor: Precision Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-10-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-Small Cell Lung Cancer patients undergoing surgery for resection of disease from hospital based locations.

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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
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Locations:
city: Birmingham
country: United States
facility: Cardio-Thoracic Surgeons, P. C.
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Stuart
country: United States
facility: Martin Memorial Treasure Coast Surgeons
state: Florida
city: Louisville
country: United States
facility: Baptist Hospital East
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Centennial Thoraic Surgeons
state: Tennessee
Study officials:
References: