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Adrenal Vein Sampling as a Tool to Identify Biomarkers That Aid the Diagnosis of Adrenocortical Carcinoma (AVS for ACC)

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ClinicalTrials.gov Identifier: NCT05660889
Recruitment Status : Recruiting
First Posted : December 21, 2022
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Richard Feelders, Erasmus Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
Adrenocortical Carcinoma Other: Blood sampling.

Study Design
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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Adrenal Vein Sampling as a Tool to Identify Biomarkers That Aid the Diagnosis of Adrenocortical Carcinoma
Actual Study Start Date : October 23, 2022
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Study group
Five patients with strong clinical suspicion of adrenocortical carcinoma
 Other: Blood sampling.
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.
 Other: Blood sampling.
Blood samples from both study groups, taken during an adrenal vein sampling, will be compared across the groups.


Outcome Measures
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Primary Outcome Measures :
  1. MicroRNA profile [ Time Frame: 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. ]
    miRNAs with a log2Fold change > |1| difference in expression in patient compared to control samples.

  2. Presence of mutations in ctDNA [ Time Frame: 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 will be assessed in patient samples and compared to control samples

  3. ctDNA methylation pattern [ Time Frame: 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 ]
    Differentially methylated probes and differentially methylated regions will be assessed as those with a beta >0.8 and <0.2

  4. Steroid profile [ Time Frame: 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 ]
    Laboratory values will be compared using Mann-Whitney-U tests


Biospecimen Retention:   Samples With DNA
Blood samples.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05660889


Contacts
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Contact: Richard Feelders, Dr. +31107032861 r.feelders@erasmusmc.nl

Locations
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Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands
Contact: Richard Feelders    +31107032861    r.feelders@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center
More Information
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Responsible Party: Richard Feelders, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT05660889    
Other Study ID Numbers: NL81124.078.22
First Posted: December 21, 2022    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Adrenal Cortex Neoplasms
 Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases