Adrenal Vein Sampling as a Tool to Identify Biomarkers That Aid the Diagnosis of Adrenocortical Carcinoma (AVS for ACC)

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.

Study Overview

• Status: Recruiting
• Conditions: Adrenocortical Carcinoma
• Intervention / Treatment: Other: Blood sampling.

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Richard Feelders, Dr.; Phone Number: +31107032861; Email: r.feelders@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus MC
    • Contact: Richard Feelders; Phone Number: +31107032861; Email: r.feelders@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with a strong clinical suspicion of adrenocortical carcinoma. The control population consists of patients without suspicion of malignancy. The most important for the participants in the control group is that their routine diagnostic tests should include an adrenal vein sampling.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Five patients with strong clinical suspicion of adrenocortical carcinoma	Other: Blood sampling.; Blood samples from both study groups, taken during an adrenal vein sampling, will be compared across the groups.
Control group; Twenty patients without suspicion of adrenal malignancy. These patients should undergo an adrenal vein sampling as part of their routine diagnostics.	Other: Blood sampling.; Blood samples from both study groups, taken during an adrenal vein sampling, will be compared across the groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Estimate): December 21, 2022

Study Record Updates

• Last Update Posted (Estimate): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Carcinoma; Adrenocortical Carcinoma
• Other Study ID Numbers: NL81124.078.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No