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NCT05763511Recruiting

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

Source: ClinicalTrials.gov · Last updated 9 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
4 Jul 2022
Start date
1 Jul 2022
Primary completion date
4 Dec 2024
Lead sponsor
University of Aarhus
NCT number
NCT05763511

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 1 Jul 2022 to the primary completion date, 4 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous ovarian cancer diagnosis

Other

  • Inability to give informed consent

Who the study is looking for

  • Suspected ovarian neoplasm
  • Informed consent

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Department of Gynaecology and Obstetrics, Aarhus University Hospital
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AarhusDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.