Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples (SAGE)
This study has suspended participant recruitment.
(Awaiting funding renewal)
Sponsor:
British Columbia Cancer Agency
Collaborator:
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00629577
First received: March 5, 2008
Last updated: November 3, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Precancerous Condition |
Genetic: microarray analysis Other: flow cytometry Procedure: biopsy Procedure: colposcopy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions |
Resource links provided by NLM:
Further study details as provided by British Columbia Cancer Agency:
Primary Outcome Measures:
- Classification of cervical cancer progression at a molecular level using gene expression profiling [ Designated as safety issue: No ]
- Gene expression changes by microarray [ Designated as safety issue: No ]
- Set of genes that classify the various grades of cervical cancer/dysplasia [ Designated as safety issue: No ]
- Comparison of the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629577
Locations
| Canada, British Columbia | |
| BC Cancer Research Centre | |
| Vancouver, British Columbia, Canada, V5Z 1L3 | |
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
| Principal Investigator: | Thomas G Ehlen, M.D. | BC Cancer Agency, Vancouver General Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sylvia Lam, research assistant, BCCA |
| ClinicalTrials.gov Identifier: | NCT00629577 History of Changes |
| Other Study ID Numbers: | CDR0000581308, R01CA103830, BCCR-H05-60100 |
| Study First Received: | March 5, 2008 |
| Last Updated: | November 3, 2010 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by British Columbia Cancer Agency:
|
cervical cancer cervical intraepithelial neoplasia grade 1 cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Precancerous Conditions Neoplastic Processes Cervical Intraepithelial Neoplasia Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Pathologic Processes Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013