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

Recruiting

• Conditions: adrenal cancer; Adrenocortical cancer; 10001353; 10014713

• Registration Number: NL-OMON51376
• Lead Sponsor: Interne Geneeskunde, Endocrinologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• 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 (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

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 <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 invasive
• Study Design: Not specified