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Brief Title: Exploration of DNA Methylation as a Marker for Early Detection of High Grade Serous Epithelial Ovarian Cancer
Official Title: Exploration of DNA Methylation as a Marker for Early Detection of High Grade Serous Epithelial Ovarian Cancer
Study ID: NCT03622385
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Baylor University Medical Center, Dallas, Texas, United States
Name: Jack Stecher, MD
Affiliation: Baylor Health Care System
Role: PRINCIPAL_INVESTIGATOR