Viewing Study NCT00175578



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Study NCT ID: NCT00175578
Status: UNKNOWN
Last Update Posted: 2011-11-16
First Post: 2005-09-13

Brief Title: Detection of Early Lung Cancer by Serum Protein Expression Profiling
Sponsor: University of British Columbia
Organization: University of British Columbia

Study Overview

Official Title: Differences in SELDI Produced Serum Protein Profiles of Non-small Cell Lung Cancer Patients Compared to Healthy Heavy Smoking Adults
Status: UNKNOWN
Status Verified Date: 2011-11
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Promising new technology exists to examine small proteins that are shed by cancers into the blood stream The purpose of this study is to see if there are differences in the proteins and protein levels in blood from individuals with early stage lung cancer compared to healthy adults
Detailed Description: A prospective longitudinal patient-based pilot study is proposed whereby surfaced enhanced laser desorption ionization time-of-flight mass spectroscopy SELDI-TOF-MS will be used to discover and validate serum proteomic expression profiles diagnostic of early lung cancer A unique approach will be used to compare the serum proteomic expression profiles of patients with non-small cell lung cancer compared to healthy heavy smoking adults as well as differences before and after anatomic pulmonary resection with curative intent Discriminatory proteins will be selected by their differential expression before compared to after surgical removal of a tumor The protein profile of blood obtained from the draining pulmonary vein at the time of resection will be used to identify materials potentially shed by the tumor that may serve as biomarkers in peripheral blood The serum samples will be used to develop a training data set and then a test set for validation using a class prediction model Candidate proteomic patterns will then serve as a basis for a larger prospective multi-centre clinical trial

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None