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

Recruiting

• Conditions: Ovary Cancer; Ovarian Neoplasms; Ovarian Cysts

• Registration Number: NCT05763511
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-12-04
• Study Completion: 2029-05-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Suspected ovarian neoplasm
• Informed consent

Exclusion Criteria

• Inability to give informed consent
• Previous ovarian cancer diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Treatment response	2 years	Response to treatment
Survival	5 years	Survival rate
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
Tumour Biology	6 months	Mutational profile assessed by Whole Exome Sequencing.

Trial Locations

Locations (1)

Department of Gynaecology and Obstetrics, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark