Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Biomarkers (genes and proteins) of lymph node involvement
研究概览
简要总结
The purpose of this study is to measure the levels of serum proteins and other biomarkers in cervical cancer patients. We believe that some of these markers may be useful in selecting patients for specific types of cancer therapies. These markers may also help to predict response to therapy, relapse after therapy, and survival after therapy.
详细描述
SPECIFIC STUDY AIMS
Specific Aim 1: To use gene expression analysis of primary cervical cancers to identify a gene expression signature that predicts for lymph node metastases in this disease.
Specific Aim 2: To predict lymph node metastases by performing multiplex measurements of cancer-associated proteins and cytokines using proximity ligation assay (PLA) on plasma samples.
Specific Aim 3: To measure circulating human papilloma virus (HPV) DNA in the plasma samples of cervical cancer patients using real-time quantitative polymerase chain reaction (qPCR) and determine its ability to predict for nodal metastases.
Specific Aim 4: To use deep sequencing to evaluate gene and sequence differences between cervical cancer patients with and without lymph node metastasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a known or suspected cervical cancer.
- •Age >=18 years.
- •Patients must have no other active cancer at the time of diagnosis.
- •Patients must have no history of a hysterectomy.
- •Patients must be able to give informed consent.
- •Patients must be willing to undergo a biopsy of the cervical tumor to provide tissue for the study.
- •Patients must have completed a standard-of-care FDG-PET/CT prior to initiation of therapy, for assessment of lymph nodes.
排除标准
- •Pregnant women
结局指标
主要结局
Biomarkers (genes and proteins) of lymph node involvement
时间窗: 4 years
次要结局
未报告次要终点