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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01450553

Enrollment

450

Registered

2011-10-12

Start date

2011-10-31

Completion date

Unknown

Last updated

2012-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

Tissue Collection, Lung Cancer, Non-Small Cell Lung Cancer, Early Stage Lung Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

United States

Contacts

Primary ContactHong Ma, MD

rd110@ptilabs.com1-877-233-7090

Outcome results