Exploration of DNA Methylation as a Marker for Early Detection of High Grade Serous Epithelial Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Identification of DNA markers using HiSeq Genome Analyzer that can predict Serous Epithelial Ovarian Cancer
研究概览
简要总结
The purpose of this study is to determine if there are markers in plasma that can be used to develop a diagnostic panel for early detection and diagnosis of high grade serous epithelial ovarian cancer.
详细描述
This study has two phases: "Discovery" cohort and "Validation" cohort.
The "Discovery" phase of this study will obtain tissue samples in a retrospective manner. The investigators will perform genome-scale DNA Methylation analysis to obtain a panel of candidate methylated DNA biomarkers. Twenty archival primary serous epithelial ovarian cancer and twenty archival normal ovarian and salpingeal tissues will be identified by running a report of diagnosis.
During the "Validation" phase of this study, blood and tissue samples will be obtained in a prospective manner. The patients will be undergoing consultation for undiagnosed pelvic mass and are being scheduled for a diagnostic laparoscopic biopsy. At the time of their consultation, patients will be recruited and consented for this phase of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older
- •Women with an undiagnosed pelvic mass who need to undergo diagnostic laparoscopic surgery
排除标准
- •Under 18 years of age
- •Women who can not give informed consent
研究组 & 干预措施
Patients diagnosed with Serous Epithelial Ovarian Cancer
Discovery Cohort: patients who were diagnosed with serous epithelial ovarian cancer whose tissue specimens were previously collected.
Validation Cohort: patients who are scheduled for a diagnostic laparoscopic biopsy for an undiagnosed pelvic mass that is determined to be cancerous.
干预措施: DNA Methylation (Other)
Normal patients
Discovery Cohort: patients who were determined to have normal ovarian tissue specimens that were previously collected.
Validation Cohort: patients who are scheduled for a diagnostic laparoscopic biopsy for an undiagnosed pelvic mass that is determined to not be cancerous.
干预措施: DNA Methylation (Other)
结局指标
主要结局
Identification of DNA markers using HiSeq Genome Analyzer that can predict Serous Epithelial Ovarian Cancer
时间窗: 2 years
Isolate DNA using QiaAMp DNA mini kits from tissue and plasma samples from subjects with serous epithelial ovarian cancer and normal subjects and then sequence the DNA using HiSeq Genome Analyzer. The investigators will identify the sequence reads using Illumina base-calling software and analyze them using Zymo Research proprietary analysis pipeline to identify differences in genomic expression in normal subjects compared to subjects with Serous Epithelial Ovarian Cancer.
次要结局
未报告次要终点