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Trial Title:
Detection of Early Lung Cancer by Serum Protein Expression Profiling
NCT ID:
NCT00175578
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Early stage (0/I) non-small cell lung cancer
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients with non-small cell lung cancer and healthy heavy smoking adults.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Presence of early stage non-small cell lung cancer
- Elective surgical resection of lung lesion at Vancouver General Hospital (VGH)
- No preoperative chemoradiation therapy
- No previous cancer
- Ability to provide informed consent
Gender:
All
Minimum age:
45 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Vancouver General Hospital BC Cancer Agency
Address:
City:
Vancouver
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Jennifer Rattenbury
Phone:
604-875-4111
Phone ext:
62183
Investigator:
Last name:
John Yee, MD
Email:
Principal Investigator
Start date:
May 2005
Completion date:
December 2011
Lead sponsor:
Agency:
University of British Columbia
Agency class:
Other
Source:
University of British Columbia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00175578