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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

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