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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05763511

Enrollment

300

Registered

2023-03-10

Start date

2022-07-01

Completion date

2029-05-04

Last updated

2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cysts, Ovarian Neoplasms, Ovary Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Suspected ovarian neoplasm * Informed consent

Exclusion criteria

* Inability to give informed consent * Previous ovarian cancer diagnosis

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Denmark

Contacts

Primary ContactIna Marie Dueholm Hjorth, MD

imhjorth@gmail.com+4526192456

Outcome results