ctDNA Methylation for Detecting Ovarian Cancer

March 24, 2023 updated by: Lei Li

Exploration of Plasma CDO1 and HOXA9 DNA Methylation for Detecting Epithelial Ovarian Cancer: A Clinical Trial in China

Ovarian cancer is one of the most dangerous and leading gynecological cancer, with significant cancer-related mortality among women. However, current detection methods are still limited, with approximately 70% of patients with high-grade serous ovarian cancer often being advanced at the initial diagnosis and more than 80% with intraperitoneal spread. The five-year survival rate for late detection is only 29%; on the contrary, if detected early, the five-year survival rate can reach 92%. Therefore, early diagnosis and detection are essential in diagnosing and treating ovarian cancer. Liquid biopsy has attracted widespread attention because of its non-invasive, real-time, and dynamic characteristics. Cell-free DNA in plasma can identify a small tumor burden well and reflect the clinical cancer information of cells.The role of hypermethylation in developing malignant tumors has received increasing attention. Methylation is one of epigenetics and plays a vital role in the occurrence and development of tumors. According to previous research basis of the researchers, it has been found that CDO1 and HOXA9 genes show hypermethylation in ovarian cancer, and they are considered one of the biomarkers for detection. Therefore, this study will further explore the detection of CDO1 and HOXA9 methylation levels based on cell-free DNA in blood and compared with ovarian pathology results; the application of methylation detection technology in ovarian cancer/precancerous lesions will further explore the application value of non-invasive diagnosis and prognostic follow-up.This study will involve three centers and is expected to enroll more than 1,400 clinical subjects, further examine the consistency of methylation detection kits with the histopathological examination, ROMA index, and Sanger sequencing results, and obtain sensitivity and specificity technical performance parameters.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study has two phases: the "Clinical Performance Validation" cohort and the "Assay Accuracy Verification" cohort.

The " Clinical Performance Validation" phase of this study will assess the reagents to detect plasma samples; patients undergo routine examinations by clinical trial institutions, including but not limited to tumor markers and histopathological examinations. The clinical performance of the assessment reagents was systematically evaluated by evaluating the consistency between the test results of the assessment reagents and the histopathological examination results, as well as the surface of the ROMA index and the histopathological examination results.

During the "Assay Accuracy Verification" phase of this study, a part of the qualified samples was randomly selected. The Sanger sequencing method was used as a comparison method to evaluate the detection accuracy of the test reagents for detecting the methylation of CDO1 and HOXA9 genes.

Study Type

Observational

Enrollment (Anticipated)

1400

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Lei Li

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients ready for surgical treatment for pelvic mass or adnexal mass. The study will also enroll several patients with primary breast cancer, lung cancer, colon cancer, uterine cervical cancer and uterine carcinomas.

Description

Inclusion Criteria:

  • Patients ready for surgical treatment for pelvic mass or adnexal mass
  • Age is greater than or equal to 18 years
  • Not receiving any chemotherapy, physical therapy, or surgical treatment for ovarian lesions
  • With ovarian pathology
  • Willing to be tested and signed an informed consent form
  • With available data of plasma CA125, Human epididymis protein 4 and effective imaging results
  • The study will also enroll several patients with primary breast cancer, lung cancer, colon cancer, uterine cervical cancer and uterine carcinomas

Exclusion Criteria:

  • Not meeting all the including criteria
  • A sample of patients withdrawing from the trial
  • Samples that the investigator believes should be excluded from this trial

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic sensitivity
Time Frame: One month
Diagnostic sensitivity of methylation assay for detecting epithelial ovarian cancer
One month
Diagnostic specificity
Time Frame: One month
Diagnostic specificity of methylation assay for detecting epithelial ovarian cancer
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Two years
Progression-free survival after the last treatment for cancer
Two years

Collaborators and Investigators

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

Sponsor

Lei Li

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)

March 24, 2023

Primary Completion (Anticipated)

March 24, 2024

Study Completion (Anticipated)

March 24, 2026

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOC-METHY2

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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