Adrenal vein sampling as a tool to identify biomarkers that aid the diagnosis of adrenocortical carcinoma

Adrenal vein sampling as a tool to identify biomarkers that aid the diagnosis of adrenocortical carcinoma - AVS for ACC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51376

Enrollment

Registered

2022-08-04

Start date

2022-10-23

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adrenal cancer Adrenocortical cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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 years - High clinical suspicion of adrenocortical carcinoma (ACC), 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 adrenal vein sampling (AVS) - No suspicion of malignancy - Able to provide signed informed consent In case pathological diagnosis from a subject who was initially assessed as eligible for the study group does not confirm ACC, this subject will be included in the control group and the samples will be analyzed as such.

Exclusion criteria

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 AVS the anticoagulants are already stopped for the following adrenal surgery, and in case of using vitamin K antagonizing anticoagulants the INR is

Design outcomes

Primary

Measure	Time frame
The main study parameters will be the differences in miRNA, ctDNA, circulating tumor cells and steroid profiles between ACC patients and controls without ACC, and between the diseased adrenal gland and the healthy adrenal gland of ACC patients.	—

Secondary

Measure	Time frame
Secondary endpoints include the differences in the amount of detection of miRNAs, ctDNA, circulating tumor cells and steroid profiles between adrenal venous and peripheral or central venous blood of ACC patients.	—

Countries

Netherlands

Outcome results