Adrenocortical CarcinomaAVS for ACCNCT05660889
Adrenal Vein Sampling as a Tool to Identify Biomarkers That Aid the Diagnosis of Adrenocortical Carcinoma
An observational study of Adrenocortical Carcinoma, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenocortical Carcinoma
- What is being tested?
- Blood sampling.
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Oct 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
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- Routine diagnostic process includes AVS
- No suspicion of malignancy
- Able to provide signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam
Richard Feelders, +31107032861, r.feelders@erasmusmc.nl
About this study
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
- Being tested
- Blood sampling.
- Medical subject headings
- Adrenocortical Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling.Other
Blood samples from both study groups, taken during an adrenal vein sampling, will be compared across the groups.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Five patients with strong clinical suspicion of adrenocortical carcinoma Receives: 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. Receives: Other: Blood sampling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MicroRNA profile
miRNAs with a log2Fold change > |1| difference in expression in patient compared to control samples.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start23 Oct 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenocortical CarcinomaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Feelders, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660889
- Sponsor's protocol ID
- NL81124.078.22
- Acronym
- AVS for ACC
- Status last verified
- Dec 2022
- First submitted
- 24 Nov 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenal Vein Sampling as a Tool to Identify Biomarkers That Aid the Diagnosis of Adrenocortical Carcinoma
- ClinicalTrials.gov ID
- NCT05660889
- Acronym / sponsor ID
- AVS for ACC / NL81124.078.22
- Conditions
- Adrenocortical Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 23 Oct 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Blood sampling.Five patients with strong clinical suspicion of adrenocortical carcinoma |
| Control group | – | Other: Blood sampling.Twenty patients without suspicion of adrenal malignancy. These patients should undergo an adrenal vein sampling as part of their routine diagnostics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling.Blood samples from both study groups, taken during an adrenal vein sampling, will be compared across the groups. | Other | Control group, Study group |
Primary outcome
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.
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenocortical Carcinoma, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Feelders, Dr. (+31107032861, r.feelders@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.