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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00629577

Acronym

SAGE

Enrollment

Registered

2008-03-06

Start date

2006-09-30

Completion date

2011-12-31

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Precancerous Condition

Keywords

cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3

Brief 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.

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.

Interventions

GENETICmicroarray analysis

OTHERflow cytometry

PROCEDUREbiopsy

PROCEDUREcolposcopy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026