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

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Epithelial Ovarian Cancer

Treatments: Other: DNA Methylation

Study type: Observational

Funder types: Other

Identifiers

NCT03622385

018-530

Details and patient eligibility

About

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.

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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

10 participants in 2 patient groups

Patients diagnosed with Serous Epithelial Ovarian Cancer

Description:

Discovery Cohort: patients who were diagnosed with serous epithelial ovarian cancer whose tissue specimens were previously collected. Validation Cohort: patients who are scheduled for a diagnostic laparoscopic biopsy for an undiagnosed pelvic mass that is determined to be cancerous.

Treatment:

Other: DNA Methylation

Normal patients

Description:

Discovery Cohort: patients who were determined to have normal ovarian tissue specimens that were previously collected. Validation Cohort: patients who are scheduled for a diagnostic laparoscopic biopsy for an undiagnosed pelvic mass that is determined to not be cancerous.

Treatment:

Other: DNA Methylation