To hear about similar clinical trials, please enter your email below

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

Login to your account

Did you forget your password?