Detection of Early Lung Cancer by Serum Protein Expression Profiling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00175578
Recruitment Status : Unknown
Verified November 2011 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : November 16, 2011
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease
Non-small Cell Lung Cancer

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 Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differences in SELDI Produced Serum Protein Profiles of Non-small Cell Lung Cancer Patients Compared to Healthy Heavy Smoking Adults
Study Start Date : May 2005
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with non-small cell lung cancer and healthy heavy smoking adults.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00175578

Contact: Jennifer Rattenbury 604-875-4111 ext 62183

Canada, British Columbia
Vancouver General Hospital BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada
Contact: Jennifer Rattenbury    604-875-4111 ext 62183      
Principal Investigator: John Yee, MD         
Sponsors and Collaborators
University of British Columbia
Principal Investigator: John Yee, MD University of British Columbia

Responsible Party: University of British Columbia Identifier: NCT00175578     History of Changes
Other Study ID Numbers: C04-0640
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011

Keywords provided by University of British Columbia:
Early stage (0/I) non-small cell lung cancer

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