To detect differences between ACC patients and controls without ACC, and between the diseased and healthy adrenal gland of ACC patients, in microRNA (miRNA), circulating cell-free tumor DNA (ctDNA), circulating tumor cells (CTCs), and steroid…
ID
Source
Brief title
Condition
- Adrenal gland disorders
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be the differences in miRNA, ctDNA, circulating
tumor cells and steroid profiles between ACC patients and controls without ACC,
and between the diseased adrenal gland and the healthy adrenal gland of ACC
patients.
Secondary outcome
Secondary endpoints include the differences in the amount of detection of
miRNAs, ctDNA, circulating tumor cells and steroid profiles between adrenal
venous and peripheral or central venous blood of ACC patients.
Background summary
Many patients currently undergo an adrenalectomy for an eventually benign
adenoma, because the current preoperative diagnostic workup of adrenal
incidentalomas cannot always rule out the diagnosis of adrenocortical carcinoma
(ACC). Many biomarkers have been implied in previous research to possibly be
associated with ACC. However, these markers cannot be measured reliably in
peripheral blood samples. We hypothesize that assessment of undiluted
biomarkers in adrenal veins is a promising strategy to diagnose or exclude ACC
without the need for surgery. Rationale is that the adrenal vein harbors a
100-fold higher measurable concentration of adrenal hormones compared to
peripheral blood samples from the inferior caval vein. It is likely that not
only hormones, but also molecules produced by an adrenal tumor, can be detected
more reliably and robustly in adrenal venous samples. We aim to preoperatively
identify biomarkers for either diagnosing or ruling out ACC, in blood obtained
directly from the adrenal vein instead of in peripheral blood.
Study objective
To detect differences between ACC patients and controls without ACC, and
between the diseased and healthy adrenal gland of ACC patients, in microRNA
(miRNA), circulating cell-free tumor DNA (ctDNA), circulating tumor cells
(CTCs), and steroid profiles in adrenal venous blood, in order to optimize
preoperative possibilities for diagnosing ACC.
Study design
Prospective case-control study.
Study burden and risks
This study has no specific benefits for the participating patients, but the
results are likely to have beneficial effects for future patients. The
technique to selectively sample the adrenal vein is frequently applied at the
Erasmus MC in the workup of patients with primary hyperaldosteronism, and it
can be safely performed with a success rate of >90% and with low risks.
Possible complications include rupture of the adrenal vein with a reported
incidency of 0.61%, inguinal bleeding or pain, dissection, thrombosis and
adrenal insufficiency, all with an incidency of <1% with current techniques.
Management of complications can be done conservatively in almost all cases.
Patients could possibly experience pain due to the blood sampling procedures.
Besides, the burden of patients included in this study consists of being
admitted to the hospital for one day, and therefore the time they invest in
this study. Furthermore, patients are exposed to Synacthen administration,
contrast fluid and approximately 3.6mSv of X-radiation. Patients in the control
group will not be subjected to any extra interventions for research purposes,
so these patients are not subjected to any additional risks associated with
this study.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
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 (ACC), 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 adrenal vein sampling (AVS)
- No suspicion of malignancy
- Able to provide signed informed consent
In case pathological diagnosis from a subject who was initially assessed as
eligible for the study group does not confirm ACC, this subject will be
included in the control group and the samples will be analyzed as such.
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 AVS 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81124.078.22 |