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

British Columbia Cancer Agency

Status and phase: Terminated; Phase 1

Conditions: Precancerous Condition; Cervical Cancer

Treatments: Genetic: microarray analysis; Procedure: colposcopy; Procedure: biopsy; Other: flow cytometry

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00629577

R01CA103830 (U.S. NIH Grant/Contract)

BCCR-H05-60100 (Other Identifier)

CDR0000581308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)