Ovarian Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

250

Study ID:

NCT03622385

Recruitment Status:

Active, not recruiting

Sponsor:

Baylor Research Institute

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There is 1 Location for this study

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Baylor University Medical Center
Dallas Texas, 75246, United States

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Study is for people with:

Ovarian Cancer

Estimated Enrollment:

250

Study ID:

NCT03622385

Recruitment Status:

Active, not recruiting

Sponsor:


Baylor Research Institute

How clear is this clinincal trial information?

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