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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Precision Therapeutics.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Precision Therapeutics
ClinicalTrials.gov Identifier:
NCT01450553
First received: October 7, 2011
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research and Development Study: Tissue Collection From Patients Who Are Undergoing Surgery for Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Precision Therapeutics:

Biospecimen Retention:   Samples With DNA

Human tumor tissues will be collected and preserved in three different tissue formats:

  • Fresh Frozen
  • FFPE
  • RNAlater

Estimated Enrollment: 450
Study Start Date: October 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Non-Small Cell Lung Cancer patients undergoing surgery for resection of disease from hospital based locations.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450553

Contacts
Contact: Hong Ma, MD 1-877-233-7090 rd110@ptilabs.com

Locations
United States, Alabama
Cardio-Thoracic Surgeons, P. C. Recruiting
Birmingham, Alabama, United States
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States
United States, Florida
Martin Memorial Treasure Coast Surgeons Recruiting
Stuart, Florida, United States
United States, Kentucky
Baptist Hospital East Not yet recruiting
Louisville, Kentucky, United States
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Centennial Thoraic Surgeons Recruiting
Nashville, Tennessee, United States
Sponsors and Collaborators
Precision Therapeutics
  More Information

No publications provided

Responsible Party: Precision Therapeutics
ClinicalTrials.gov Identifier: NCT01450553     History of Changes
Other Study ID Numbers: RD-110
Study First Received: October 7, 2011
Last Updated: January 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Precision Therapeutics:
Tissue Collection
Lung Cancer
Non-Small Cell Lung Cancer
Early Stage Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014