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

NCT ID: NCT05660889

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-23

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adrenocortical Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Five patients with strong clinical suspicion of adrenocortical carcinoma

Blood sampling.

Intervention Type OTHER

Blood samples from both study groups, taken during an adrenal vein sampling, will be compared across the groups.

Control group

Twenty patients without suspicion of adrenal malignancy. These patients should undergo an adrenal vein sampling as part of their routine diagnostics.

Blood sampling.

Intervention Type OTHER

Blood samples from both study groups, taken during an adrenal vein sampling, will be compared across the groups.

Interventions

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Blood sampling.

Blood samples from both study groups, taken during an adrenal vein sampling, will be compared across the groups.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Richard Feelders

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erasmus MC

Rotterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Richard Feelders, Dr.

Role: CONTACT

Phone: +31107032861

Email: [email protected]

Facility Contacts

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Richard Feelders

Role: primary

Other Identifiers

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NL81124.078.22

Identifier Type: -

Identifier Source: org_study_id