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
  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)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014