Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Research and Development Study: Tissue Collection From Patients Who Are Undergoing Surgery for Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01450553
• Other study ID #: RD-110
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2011
• Last updated: January 9, 2012
• Start date: October 2011

Study information

• Verified date: January 2012
• Source: Precision Therapeutics
• Contact: Hong Ma, MD
• Phone: 1-877-233-7090
• Email: rd110[@]ptilabs.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
United States	Cardio-Thoracic Surgeons, P. C.	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Baptist Hospital East	Louisville	Kentucky
United States	Centennial Thoraic Surgeons	Nashville	Tennessee
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Martin Memorial Treasure Coast Surgeons	Stuart	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Precision Therapeutics

Country where clinical trial is conducted

United States,