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

Last updated: December 14, 2022
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Adrenal Cancer

Carcinoma

Treatment

N/A

Clinical Study ID

NCT05660889
NL81124.078.22
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: In order to be eligible to participate in the study group, a subject must meet all of thefollowing criteria:

  • Patient age ≥18 years
  • High clinical suspicion of adrenocortical carcinoma, based on clinical signs (due tohormonal 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 thefollowing criteria:
  • Patient age ≥18 years
  • Routine diagnostic process includes AVS
  • No suspicion of malignancy
  • Able to provide signed informed consent

Exclusion

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 dayof the adrenal vein sampling the anticoagulants are already stopped for the followingadrenal 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 onthe 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

Total Participants: 25
Study Start date:
October 23, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Erasmus MC

    Rotterdam,
    Netherlands

    Active - Recruiting

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