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

• Conditions: Epithelial Ovarian Cancer
• Interventions: Other: DNA Methylation

• Registration Number: NCT03622385
• Lead Sponsor: Baylor Research Institute

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.

Study Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-09
• Study Start: 2019-02-19
• Status Verified: 2021-03
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-02
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with Serous Epithelial Ovarian Cancer	DNA Methylation	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.
Normal patients	DNA Methylation	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.

Primary Outcome Measures

Name	Time	Method
Identification of DNA markers using HiSeq Genome Analyzer that can predict Serous Epithelial Ovarian Cancer	2 years	Isolate DNA using QiaAMp DNA mini kits from tissue and plasma samples from subjects with serous epithelial ovarian cancer and normal subjects and then sequence the DNA using HiSeq Genome Analyzer. The investigators will identify the sequence reads using Illumina base-calling software and analyze them using Zymo Research proprietary analysis pipeline to identify differences in genomic expression in normal subjects compared to subjects with Serous Epithelial Ovarian Cancer.

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States