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Recruiting NCT05660889

Adrenal Vein Sampling as a Tool to Identify Biomarkers That Aid the Diagnosis of Adrenocortical Carcinoma

Conditions: Adrenocortical Carcinoma

Sex: All
Ages: 18 Years – N/A
Enrollment: 25
Sponsor: Erasmus Medical Center

Location: Netherlands

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.

Eligibility Criteria

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 yearsHigh 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 consentIn order to be eligible to participate in the control group, a subject must meet all of the following criteria:Patient age ≥18 yearsRoutine diagnostic process includes AVSNo suspicion of malignancyAble to provide signed informed consentExclusion Criteria:Patients are not able to participate if:They have a known allergy to (iodinated) contrast fluidThey 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 <3The platelet count is below 20Anatomy of the adrenal vein is not suitable for performing the AVS procedure, based on the judgement of an experienced interventional radiologistContraindications for use of SynacthenThey have a known hypersensitivity to any of the substances of SynacthenThey are pregnant

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05660889). StuddyBuddy aggregates publicly available trial information.