Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Classification of cervical cancer progression at a molecular level using gene expression profiling
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Clinically suspicious malignant or premalignant cervical lesion
- •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.
排除标准
- •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.
结局指标
主要结局
Classification of cervical cancer progression at a molecular level using gene expression profiling
Gene expression changes by microarray
Comparison of the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment
Set of genes that classify the various grades of cervical cancer/dysplasia
次要结局
未报告次要终点