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

NCT05660889 | Unknown

• 1 other identifier: NL81124.078.22
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adrenocortical Carcinoma

Outcome Measures

Primary Outcomes (4)

• MicroRNA profile

  miRNAs with a log2Fold change \> \|1\| difference in expression in patient compared to control samples.

  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.

• Presence of mutations in ctDNA

  Presence of mutations will be assessed in patient samples and compared to control samples

  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

• ctDNA methylation pattern

  Differentially methylated probes and differentially methylated regions will be assessed as those with a beta \>0.8 and \<0.2

  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

• Steroid profile

  Laboratory values will be compared using Mann-Whitney-U tests

  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

Study Arms (2)

Study group

Five patients with strong clinical suspicion of adrenocortical carcinoma

Other: Blood sampling.

Control group

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

Other: Blood sampling.

Interventions

Blood sampling. OTHER

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

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Adrenocortical Carcinoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Richard Feelders, Dr.

CONTACT

+31107032861; r.feelders@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 21, 2022
• Study Start: October 23, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 31, 2024
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

NL (1)