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

January 31, 2022 updated by: Baylor Research Institute
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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients who will be recruited for the prospective phase of the study will be women, 18 years of age or older, who have an undiagnosed pelvic mass who need to undergo diagnostic laparoscopic surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with Serous Epithelial Ovarian Cancer

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.

No intervention will be performed. Blood and tissue samples will be analyzed for biomarkers that may be used to develop a diagnostic panel for early detection and diagnosis of high grade serous epithelial ovarian cancer.
Normal patients

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.

No intervention will be performed. Blood and tissue samples will be analyzed for biomarkers that may be used to develop a diagnostic panel for early detection and diagnosis of high grade serous epithelial ovarian cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of DNA markers using HiSeq Genome Analyzer that can predict Serous Epithelial Ovarian Cancer
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jack Stecher, MD, Baylor Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2019

Primary Completion (Anticipated)

March 8, 2022

Study Completion (Anticipated)

March 8, 2022

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 2, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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