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

Recruiting

• Conditions: Adrenocortical Carcinoma
• Interventions: Other: Blood sampling.

• Registration Number: NCT05660889
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-23
• Study First Submitted: 2022-11-24
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-14
• Last Update Submitted: 2022-12-14
• Study First Posted: 2022-12-21
• Last Update Posted: 2022-12-21
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Blood sampling.	Five patients with strong clinical suspicion of adrenocortical carcinoma
Control group	Blood sampling.	Twenty patients without suspicion of adrenal malignancy. These patients should undergo an adrenal vein sampling as part of their routine diagnostics.

Primary Outcome Measures

Name	Time	Method
MicroRNA profile	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.	miRNAs with a log2Fold change \> \|1\| difference in expression in patient compared to control samples.
Presence of mutations in ctDNA	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	Presence of mutations will be assessed in patient samples and compared to control samples
ctDNA methylation pattern	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	Differentially methylated probes and differentially methylated regions will be assessed as those with a beta \>0.8 and \<0.2
Steroid profile	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	Laboratory values will be compared using Mann-Whitney-U tests

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands