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Trial Title:
Adrenal Vein Sampling as a Tool to Identify Biomarkers That Aid the Diagnosis of Adrenocortical Carcinoma
NCT ID:
NCT05660889
Condition:
Adrenocortical Carcinoma
Conditions: Official terms:
Carcinoma
Adrenocortical Carcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Blood sampling.
Description:
Blood samples from both study groups, taken during an adrenal vein sampling, will be
compared across the groups.
Arm group label:
Control group
Arm group label:
Study group
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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, 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Richard Feelders
Phone:
+31107032861
Email:
r.feelders@erasmusmc.nl
Start date:
October 23, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05660889
