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Detection of Early Lung Cancer by Serum Protein Expression Profiling

NCT ID: NCT00175578

Last Updated: 2011-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Yee, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Vancouver General Hospital BC Cancer Agency

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jennifer Rattenbury

Role: CONTACT

[email protected]
604-875-4111 ext. 62183

Facility Contacts

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Jennifer Rattenbury

Role: primary

604-875-4111 ext. 62183

Other Identifiers

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C04-0640

Identifier Type: -

Identifier Source: org_study_id