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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03622385
Study type Observational
Source Baylor Research Institute
Contact
Status Active, not recruiting
Phase
Start date February 19, 2019
Completion date March 8, 2022

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