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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05660889
Other study ID # NL81124.078.22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 23, 2022
Est. completion date December 31, 2024

Study information

Verified date December 2022
Source Erasmus Medical Center
Contact Richard Feelders, Dr.
Phone +31107032861
Email r.feelders@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational pilot study is to explore whether we can identify biomarkers predictive for the diagnosis of adrenocortical carcinoma in blood. Five participants who are suspected to have adrenocortical carcinoma will undergo an adrenal vein sampling in order to obtain a blood sample from the adrenal vein. This blood sample will be analyzed and compared to blood samples taken from the adrenal vein of 20 control patients, which are patients who do not have adrenocortical carcinoma. The blood samples of the control patients will be drawn during routine medical care.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 31, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: In order to be eligible to participate in the study group, a subject must meet all of the following criteria: - Patient age =18 years - High clinical suspicion of adrenocortical carcinoma, based on clinical signs (due to hormonal overproduction), steroid hormone profile and radiological features (e.g. tumor size =4cm, inhomogenous aspect and tumor attenuation of HU =10) - Able to provide signed informed consent In order to be eligible to participate in the control group, a subject must meet all of the following criteria: - Patient age =18 years - Routine diagnostic process includes AVS - No suspicion of malignancy - Able to provide signed informed consent Exclusion Criteria: Patients are not able to participate if: - They have a known allergy to (iodinated) contrast fluid - They use vitamin K antagonizing anticoagulants or DOAC's, except for when on the day of the adrenal vein sampling the anticoagulants are already stopped for the following adrenal surgery, and in case of using vitamin K antagonizing anticoagulants the INR is <3 - The platelet count is below 20 - Anatomy of the adrenal vein is not suitable for performing the AVS procedure, based on the judgement of an experienced interventional radiologist - Contraindications for use of Synacthen - They have a known hypersensitivity to any of the substances of Synacthen - They are pregnant

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood sampling.
Blood samples from both study groups, taken during an adrenal vein sampling, will be compared across the groups.

Locations

Country Name City State
Netherlands Erasmus MC Rotterdam

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary MicroRNA profile miRNAs with a log2Fold change > |1| difference in expression in patient compared to control samples. Analyses will be done at the end of inclusion of all patients, this will be after 2 years. Blood drawn before surgery/treatment will be analysed.
Primary Presence of mutations in ctDNA Presence of mutations will be assessed in patient samples and compared to control samples Analyses will be done at the end of inclusion of all patients, this will be after 2 years. Blood drawn before surgery/treatment will be analysed
Primary ctDNA methylation pattern Differentially methylated probes and differentially methylated regions will be assessed as those with a beta >0.8 and <0.2 Analyses will be done at the end of inclusion of all patients, this will be after 2 years. Blood drawn before surgery/treatment will be analysed
Primary Steroid profile Laboratory values will be compared using Mann-Whitney-U tests Analyses will be done at the end of inclusion of all patients, this will be after 2 years. Blood drawn before surgery/treatment will be analysed
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