Exploration of DNA Methylation as a Marker for Early Detection of High Grade Serous Epithelial Ovarian Cancer



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/18/2019
Start Date:January 2019
End Date:October 2021
Contact:Jack Stecher, MD
Email:jackstecher@sbcglobal.net
Phone:214-820-2126

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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.

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.

Inclusion Criteria:

- Female

- 18 years of age and older

- Women with an undiagnosed pelvic mass who need to undergo diagnostic laparoscopic
surgery

Exclusion Criteria:

- Male

- Under 18 years of age

- Women who can not give informed consent
We found this trial at
1
site
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Jack Stecher, MD
Phone: 214-820-2126
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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