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

Sponsor

University of Aarhus (Other)

Overall Status

Recruiting

CT.gov ID

NCT05763511

Collaborator

Aarhus University Hospital (Other)

300

Enrollment

Location

82.1

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasms Ovary Cancer Ovarian Cysts

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

May 4, 2024

Anticipated Study Completion Date :

May 4, 2029

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Suspected ovarian neoplasm
Informed consent

Exclusion Criteria:

Inability to give informed consent
Previous ovarian cancer diagnosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gynaecology and Obstetrics, Aarhus University Hospital	Aarhus		Denmark

Sponsors and Collaborators

University of Aarhus
Aarhus University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ina Marie Dueholm Hjorth, Medical doctor, PhD student, University of Aarhus

ClinicalTrials.gov Identifier:

NCT05763511

Other Study ID Numbers:

Ovarian cancer ctDNA

First Posted:

Mar 10, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ovarian Neoplasms

Ovarian Cysts

Study Results

No Results Posted as of Mar 13, 2023