Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples (SAGE)
Primary Purpose
Cervical Cancer, Precancerous Condition
Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
microarray analysis
flow cytometry
biopsy
colposcopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer focused on measuring cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
Eligibility 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.
Sites / Locations
- BC Cancer Research Centre
Outcomes
Primary Outcome Measures
Classification of cervical cancer progression at a molecular level using gene expression profiling
Gene expression changes by microarray
Set of genes that classify the various grades of cervical cancer/dysplasia
Comparison of the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment
Secondary Outcome Measures
Full Information
NCT ID
NCT00629577
First Posted
March 5, 2008
Last Updated
January 30, 2017
Sponsor
British Columbia Cancer Agency
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00629577
Brief Title
Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples
Acronym
SAGE
Official Title
Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
no funding
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial is studying gene expression profiling of cervical cancer progression in biopsies and tissue samples from patients with cervical lesions.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Precancerous Condition
Keywords
cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
colposcopy
Primary Outcome Measure Information:
Title
Classification of cervical cancer progression at a molecular level using gene expression profiling
Title
Gene expression changes by microarray
Title
Set of genes that classify the various grades of cervical cancer/dysplasia
Title
Comparison of the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas G Ehlen, M.D.
Organizational Affiliation
BC Cancer Agency, Vancouver General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Cancer Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L3
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples
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