Clinical trial · Observational
Adrenal Vein Sampling as a Tool to Identify Biomarkers That Aid the Diagnosis of Adrenocortical Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenocortical Carcinoma | Adrenal Cortical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Study group
- description
- Five patients with strong clinical suspicion of adrenocortical carcinoma
- interventionNames
- Other: Blood sampling.
- label
- Control group
- description
- Twenty patients without suspicion of adrenal malignancy. These patients should undergo an adrenal vein sampling as part of their routine diagnostics.
- interventionNames
- Other: Blood sampling.
Primary outcomes (4)
- measure
- MicroRNA profile
- timeFrame
- 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.
- description
- miRNAs with a log2Fold change \> \|1\| difference in expression in patient compared to control samples.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available