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NCT05763511 Clinical Trial

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

Ovarian Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05763511
Other study ID # Ovarian cancer ctDNA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date May 4, 2029

Study information
Verified date May 2024
Source University of Aarhus
Contact Ina Marie Dueholm Hjorth, MD
Phone +4526192456
Email imhjorth@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date May 4, 2029
Est. primary completion date December 4, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Suspected ovarian neoplasm - Informed consent Exclusion Criteria: - Inability to give informed consent - Previous ovarian cancer diagnosis

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Department of Gynaecology and Obstetrics, Aarhus University Hospital Aarhus

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

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