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 |
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.
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.
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
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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