Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker

May 8, 2024 updated by: Ina Marie Dueholm Hjorth, University of Aarhus

This project investigates circulating tumor DNA (ctDNA) in patients with suspected ovarian malignancy.

We hypothesize that measurement of ctDNA in women with suspected ovarian cancer can improve the diagnostic efficiency for preoperative differentiation between benign and malignant masses.

Specifically, we hope to determine the diagnostic efficiency of ctDNA alone and ctDNA in combination with imaging modalities (ultrasonography, MRI, PET-CT) and CA 125 for preoperative differentiation between benign and malignant adnexal masses. Based on this, we hope to develop an improved diagnostic algorithm.

The mutational profile and relation to tumour type, stage, treatment response and prognosis will be explored.

Analyses of blood and tissue samples will be used to examine the disease development and biology.

Blood samples, tumour tissue and data on imaging modalities as well as CA 125 will be collected prospectively in consecutive women referred to Aarhus University Hospital.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

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

Study Contact

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Department of Gynaecology and Obstetrics, Aarhus University Hospital
        • Contact:
          • Ina Marie Dueholm Hjorth, MD
          • Phone Number: +45 26192456

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

Sampling Method

Probability Sample

Study Population

Patients referred due to suspected ovarian cancer

Description

Inclusion Criteria:

  • Suspected ovarian neoplasm
  • Informed consent

Exclusion Criteria:

  • Inability to give informed consent
  • Previous ovarian cancer diagnosis

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 efficiency (reference: histopathological diagnosis)
Time Frame: 6 months
Sensitivity, Specificity, Area under the receiver operation characteristic curve, positive and negative predictive values.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 5 years
Survival rate
5 years
Diagnostic efficiency of ctDNA combined with imaging (ultrasonography, MRI, PET-CT, CT, etc.) and CA 125 for differentiation of benign and malignant adnexal masses.
Time Frame: 6 months
Area under the receiver operation characteristic curve, sensitivity, specificity, positive and negative predictive values.
6 months
Disease stage
Time Frame: 6 months
FIGO stage
6 months
Treatment response
Time Frame: 2 years
Response to treatment
2 years
Tumour Biology
Time Frame: 6 months
Mutational profile assessed by Whole Exome Sequencing.
6 months

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Ina Marie Dueholm Hjorth, MD, University of Aarhus

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)

July 1, 2022

Primary Completion (Estimated)

December 4, 2024

Study Completion (Estimated)

May 4, 2029

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ovarian cancer ctDNA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Depending on GDPR regulations

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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