Ovarian NeoplasmsNCT05763511
Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
An observational study of Ovarian Neoplasms and Ovary Cancer, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Ovary Cancer, Ovarian Cysts
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2022to 4 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred due to suspected ovarian cancer
Who may be able to join
- Suspected ovarian neoplasm
- Informed consent
Who cannot join
- Inability to give informed consent
- Previous ovarian cancer diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus
Ina Marie Dueholm Hjorth, MD, +45 26192456
About this study
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.
Read more
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.
- Conditions
- Ovarian Neoplasms, Ovary Cancer, Ovarian Cysts
- Medical subject headings
- Ovarian Neoplasms, Ovarian Cysts
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficiency (reference: histopathological diagnosis)
Sensitivity, Specificity, Area under the receiver operation characteristic curve, positive and negative predictive values.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 6 months
Disease stage
FIGO stage
Measured: 6 months
Treatment response
Response to treatment
Measured: 2 years
Survival
Survival rate
Measured: 5 years
Tumour Biology
Mutational profile assessed by Whole Exome Sequencing.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Jul 2022
- Primary completion4 Dec 2024 (estimated)
- Study completion4 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Ina Marie Dueholm Hjorth, University of Aarhus
- Investigators
- Ina Marie Dueholm Hjorth, MD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763511
- Sponsor's protocol ID
- Ovarian cancer ctDNA
- Status last verified
- May 2024
- First submitted
- 4 Jul 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Depending on GDPR regulations
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
- ClinicalTrials.gov ID
- NCT05763511
- Acronym / sponsor ID
- Ovarian cancer ctDNA
- Conditions
- Ovarian Neoplasms, Ovary Cancer, Ovarian Cysts
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 4 Dec 2024 (estimated)
- Study completion
- 4 May 2029 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred due to suspected ovarian cancer
Key inclusion criteria (2 listed)
- Suspected ovarian neoplasm
- Informed consent
Key exclusion criteria (2 listed)
- Inability to give informed consent
- Previous ovarian cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic efficiency (reference: histopathological diagnosis)
Time frame: 6 months
Sensitivity, Specificity, Area under the receiver operation characteristic curve, positive and negative predictive values.
5 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
Disease stage
Time frame: 6 months
Treatment response
Time frame: 2 years
Survival
Time frame: 5 years
Tumour Biology
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No. Depending on GDPR regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ina Marie Dueholm Hjorth, MD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms and Ovary Cancer, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ina Marie Dueholm Hjorth, MD (+4526192456, imhjorth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficiency (reference: histopathological diagnosis) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.