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

Precision Therapeutics

Status: Unknown

Conditions: Non-Small Cell Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01450553

RD-110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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