Recruiting

NCT Number: NCT05763511

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

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.

Recruiting

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases Cysts Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cysts Ovarian Diseases Ovary Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Gynaecology and Obstetrics, Aarhus University Hospital

Aarhus, Denmark

Location status: Recruiting

Location contact

Ina Marie Dueholm Hjorth, MD

CONTACT

+45 26192456

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Suspected ovarian neoplasm
Informed consent

Exclusion criteria

Inability to give informed consent
Previous ovarian cancer diagnosis

Treatment and study plan

Primary outcomes

Diagnostic efficiency (reference: histopathological diagnosis)

Time frame: 6 months

Sensitivity, Specificity, Area under the receiver operation characteristic curve, positive and negative predictive values.

Secondary outcomes

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.
Disease stage

Time frame: 6 months

FIGO stage
Treatment response

Time frame: 2 years

Response to treatment
Survival

Time frame: 5 years

Survival rate
Tumour Biology

Time frame: 6 months

Mutational profile assessed by Whole Exome Sequencing.

Study contacts

Contact information is provided by the study sponsor or research team.

Ina Marie Dueholm Hjorth, MD

CONTACT

[email protected]

+4526192456

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

Aarhus University Hospital

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2029
First posted: Mar 10, 2023
Registry last updated: May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting