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

Adrenocortical Carcinoma Clinical Trial

— AVS for ACC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660889
• Other study ID #: NL81124.078.22
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Adrenocortical Carcinoma
• Carcinoma

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