Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions
19 Years
N/A
Female
Cervical Cancer, Precancerous Condition
Trial Information
Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Clinically suspicious malignant or premalignant cervical lesion
Criteria
Inclusion criteria:
- Included subjects will be ≥18 years old.
- 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:
- Individuals <18 years old will be excluded.
- Pregnant individuals will be excluded.
- Individuals that have had an operation to remove their cervix will be excluded.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Classification of cervical cancer progression at a molecular level using gene expression profiling
Safety Issue:
No
Principal Investigator
Thomas G Ehlen, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
BC Cancer Agency, Vancouver General Hospital
Authority:
Canada: Canadian Institutes of Health Research
Study ID:
CDR0000581308
NCT ID:
NCT00629577
Start Date:
September 2006
Completion Date:
December 2011
Related Keywords:
- Cervical Cancer
- Precancerous Condition
- cervical cancer
- cervical intraepithelial neoplasia grade 1
- cervical intraepithelial neoplasia grade 2
- cervical intraepithelial neoplasia grade 3
- Uterine Cervical Neoplasms
- Precancerous Conditions
- Neoplastic Processes
- Cervical Intraepithelial Neoplasia
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