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

Cervical Cancer Clinical Trial

— SAGE  

Official title:

Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00629577
• Other study ID #: CDR0000581308
• Secondary ID: R01CA103830BCCR-
• Status: Terminated
• Phase: Phase 1
• First received: March 5, 2008
• Last updated: January 30, 2017
• Start date: September 2006
• Est. completion date: December 2011

Study information

• Verified date: November 2010
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Neoplasms

Intervention

Genetic:
• microarray analysis

Other:
• flow cytometry

Procedure:
• biopsy

• colposcopy

Locations

Country	Name	City	State
Canada	BC Cancer Research Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classification of cervical cancer progression at a molecular level using gene expression profiling
Primary	Gene expression changes by microarray
Primary	Set of genes that classify the various grades of cervical cancer/dysplasia
Primary	Comparison of the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment