Cushing SyndromeAVSNCT02543697
Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors
A study testing Adrenal venous sampling in people with Cushing Syndrome, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Patients with tumors in both adrenal glands and slightly elevated cortisol (subclinical Cushings syndrome) are offered to go through an adrenal venous sampling to try to quantify if the overproduction of cortisol is from one adrenal, or from both sides. If it is one-sided, the investigators offer the patient operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing Syndrome
- What is being tested?
- Adrenal venous sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2015to Feb 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign tumors/adenomas in the adrenals and biochemically overproduction of cortisol
Who cannot join
- Use of steroids ( tablets, inhalations, lotions)
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5021
Grethe Ueland, MD, +4790950021, geas@helse-bergen.no
Hrafnkell Thordason, MD, hraf@helse-bergen.no
About this study
Patients with tumors in both adrenal glands and slightly elevated cortisol (subclinical Cushings syndrome) are offered to go through an adrenal venous sampling to try to quantify if the overproduction of cortisol is from one adrenal, or from both sides. If it is one-sided, the investigators offer the patient operation.
Read the detailed description
Adrenal incidentalomas are quite common. About 4 % of the population have adrenal tumors that they are unknown of. Some percentage of this patients produce a little to much cortisol, but not enough to give overt Cushings syndrome. It is shown that slightly elevated cortisol production will give higher blood pressure, higher blood sugar and maybe higher BMI. For another hormone produced in the adrenal glands , aldosterone, we know that even if you have an adrenal tumor on one adrenal, you could have bilateral overproduction of the hormone.In that situations it is no need of an operation of the adrenal with the tumor. When the overproduction is unilateral it is of great value to the patient to operate the adrenal gland, and the symptoms from the hormone excess will disappear. For aldosterone Adrenal venous sampling (AVS) has been used for several years to try to determine if the hormone overproduction is one-sided or to sided. We are in this study using the same principle for cortisol overproduction.
- Conditions
- Cushing Syndrome
- Being tested
- Adrenal venous sampling
- Medical subject headings
- Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adrenal venous samplingRadiation
We go trough the femoral vein with a catheter up to the adrenal vein first on the left side, then on the right side. We take blood samples and analyze cortisol, metanefrin/ normetanefrin, aldosterone both from the adrenal veins and from the peripher vein. Then we use criteria from the Majo clinic to identify if the overproduction of cortisol is uni- or bilateral.
| Study group | Role | What they receive |
|---|---|---|
| Adrenal venous sampling | Experimental | Patients going trough an adrenal venous sampling to find out if hypercortisolism is uni or bilaterally produced. Receives: Radiation: Adrenal venous sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateralisation of cortisol overproduction
If the ratio between cortisol in the adrenal veins is over 3,3 , it is defined as unilateral overproduction of cortisol.
Measured: 2 yeras
Secondary outcomes (2)
Biochemically and clinically normalising after treatment
The patients will be offered operation if the overproduction seems to be unilateral. They will then be evaluated for cortisol abnormalities , blood sugar, and hypertension i intervals of 6 months after surgery ,to see if the parameters improve. They who are not operated will be evaluated in the same way.
Measured: 2 years
Verify overproduction of cortisol from the adrenals
If the ratio between cortisol in the adrenal vein and the periphery vein is over 3,3 it is defined as overproduction, and if it is over 6,5 it will probably be an adenoma.
Measured: 2 yeras
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cushing SyndromeStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grethe Ueland, MD, Principal investigator, Haukeland Univerity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543697
- Sponsor's protocol ID
- 2014/2170
- Acronym
- AVS
- Status last verified
- Sep 2016
- First submitted
- 13 Feb 2015
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ueland GA, Methlie P, Jossang DE, Sagen JV, Viste K, Thordarson HB, Heie A, Grytaas M, Lovas K, Biermann M, Husebye ES. Adrenal Venous Sampling for Assessment of Autonomous Cortisol Secretion. J Clin Endocrinol Metab. 2018 Dec 1;103(12):4553-4560. doi: 10.1210/jc.2018-01198.
PubMed 30137397
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors
- ClinicalTrials.gov ID
- NCT02543697
- Acronym / sponsor ID
- AVS / 2014/2170
- Conditions
- Cushing Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 7 Sep 2015 (estimated)
- 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.
Patients with tumors in both adrenal glands and slightly elevated cortisol (subclinical Cushings syndrome) are offered to go through an adrenal venous sampling to try to quantify if the overproduction of cortisol is from one adrenal, or from both sides. If it is one-sided, the investigators offer the patient operation.
Detailed description
Adrenal incidentalomas are quite common. About 4 % of the population have adrenal tumors that they are unknown of. Some percentage of this patients produce a little to much cortisol, but not enough to give overt Cushings syndrome. It is shown that slightly elevated cortisol production will give higher blood pressure, higher blood sugar and maybe higher BMI. For another hormone produced in the adrenal glands , aldosterone, we know that even if you have an adrenal tumor on one adrenal, you could have bilateral overproduction of the hormone.In that situations it is no need of an operation of the adrenal with the tumor. When the overproduction is unilateral it is of great value to the patient to operate the adrenal gland, and the symptoms from the hormone excess will disappear. For aldosterone Adrenal venous sampling (AVS) has been used for several years to try to determine if the hormone overproduction is one-sided or to sided. We are in this study using the same principle for cortisol overproduction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adrenal venous sampling | Experimental | Radiation: Adrenal venous samplingPatients going trough an adrenal venous sampling to find out if hypercortisolism is uni or bilaterally produced. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Benign tumors/adenomas in the adrenals and biochemically overproduction of cortisol
Key exclusion criteria (1 listed)
- Use of steroids ( tablets, inhalations, lotions)
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 |
|---|---|---|
| Adrenal venous samplingWe go trough the femoral vein with a catheter up to the adrenal vein first on the left side, then on the right side. We take blood samples and analyze cortisol, metanefrin/ normetanefrin, aldosterone both from the adrenal veins and from the peripher vein. Then we use criteria from the Majo clinic to identify if the overproduction of cortisol is uni- or bilateral. | Radiation | Adrenal venous sampling |
Primary outcome
Lateralisation of cortisol overproduction
Time frame: 2 yeras
If the ratio between cortisol in the adrenal veins is over 3,3 , it is defined as unilateral overproduction of cortisol.
2 secondary outcomes
Biochemically and clinically normalising after treatment
Time frame: 2 years
Verify overproduction of cortisol from the adrenals
Time frame: 2 yeras
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Derived from this study: PubMed 30137397Ueland GA, Methlie P, Jossang DE, Sagen JV, Viste K, Thordarson HB, Heie A, Grytaas M, Lovas K, Biermann M, Husebye ES. Adrenal Venous Sampling for Assessment of Autonomous Cortisol Secretion. J Clin Endocrinol Metab. 2018 Dec 1;103(12):4553-4560. doi: 10.1210/jc.2018-01198.
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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.
Grethe Ueland, MD principal investigator
Haukeland Univerity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenal venous sampling in people with Cushing Syndrome, run by Haukeland University Hospital at 1 site in Norway.
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 1 inclusion and 1 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 8 Sep 2016. 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 Norway. 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 Grethe Ueland, MD (+4790950021, geas@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lateralisation of cortisol overproduction (time frame: 2 yeras). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02543697, which also lists 1 linked publication.
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 8 Sep 2016.