Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples
NCT ID: NCT00629577
Last Updated: 2017-02-01
Study Results
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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TERMINATED
PHASE1
50 participants
INTERVENTIONAL
2006-09-30
2011-12-31
Brief Summary
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PURPOSE: This research trial is studying gene expression profiling of cervical cancer progression in biopsies and tissue samples from patients with cervical lesions.
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Detailed Description
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* Classify cervical cancer progression at a molecular level using gene expression profiling generated from expression microarrays.
* Profile gene expression changes of dysplasia and early carcinoma of uterine cervical tissue at a molecular level using expression microarrays.
* Define a set of genes that classify the various grades of cervical cancer/dysplasia at a molecular level.
* Compare the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment.
OUTLINE: Patients undergo colposcopy and a cervical smear is taken for flow cytometry analysis. Patients also undergo 2 biopsies from one clinically abnormal or normal site. Tissue samples are analyzed by gene expression profiling using human expression microarrays containing approximately 40,000 unique sequences. Data analysis consists of defining a set of genes, containing new targets for biomarkers, that classify the biopsies into 3 grades.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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microarray analysis
flow cytometry
biopsy
colposcopy
Eligibility Criteria
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Inclusion Criteria
* Included subjects will not be pregnant.
* Included subjects will have a negative urine pregnancy test.
* Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.
* Included subjects will indicate understanding of the study.
* Included subjects will provide informed consent to participate.
Exclusion Criteria
* Pregnant individuals will be excluded.
* Individuals that have had an operation to remove their cervix will be excluded.
19 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
British Columbia Cancer Agency
OTHER
Responsible Party
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Principal Investigators
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Thomas G Ehlen, M.D.
Role: PRINCIPAL_INVESTIGATOR
BC Cancer Agency, Vancouver General Hospital
Locations
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BC Cancer Research Centre
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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BCCR-H05-60100
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000581308
Identifier Type: -
Identifier Source: org_study_id
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