Recruiting

Observational Study

Sponsor:

Precision Therapeutics

Code:

NCT01450553

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT01450553

Start date

Oct, 2011

Status verified date

Jan, 2012

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Hong Ma, MD

1-877-233-7090rd110@ptilabs.com

Locations

Cardio-Thoracic Surgeons, P. C.

Recruiting

Birmingham, Alabama, United States

Martin Memorial Treasure Coast Surgeons

Recruiting

Stuart, Florida, United States

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States

Centennial Thoraic Surgeons

Recruiting

Nashville, Tennessee, United States

More Information

Sponsor

Precision Therapeutics

Last update posted

Jan 11, 2012

Last verified

Jan, 2012

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Precision Therapeutics on 2012-01-11.