Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples (SAGE)

This study has suspended participant recruitment.
(Awaiting funding renewal)
Sponsor:
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

March 5, 2008
November 3, 2010
September 2006
June 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00629577 on ClinicalTrials.gov Archive Site
Not Provided
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Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples
Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Cervical Cancer
  • Precancerous Condition
  • Genetic: microarray analysis
  • Other: flow cytometry
  • Procedure: biopsy
  • Procedure: colposcopy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
50
December 2011
June 2010   (final data collection date for primary outcome measure)

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.
Female
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00629577
CDR0000581308, R01CA103830, BCCR-H05-60100
No
Sylvia Lam, research assistant, BCCA
British Columbia Cancer Agency
National Cancer Institute (NCI)
Principal Investigator: Thomas G Ehlen, M.D. BC Cancer Agency, Vancouver General Hospital
British Columbia Cancer Agency
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP