We hypothesize that urinary steroid profiling is cost-effective compared to repeat CT-scanning in patients with adrenal incidentalomas.
ID
Bron
Verkorte titel
Aandoening
adrenal incidentaloma
adrenocortical carcinoma
urinary steroid profiling
Ondersteuning
Amsterdam Medical Center
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome parameter is the difference in cost-effectiveness of the current management strategy based on repeat CT-scanning to detect adrenocortical carcinoma among patients with an adrenal incidentaloma compared with a strategy using a single baseline urinary steroid profiling.
Achtergrond van het onderzoek
The standard diagnostic work-up for adrenal incidentaloma (AI) consists of biochemical analysis to detect hormonal hypersecretion and repeat CT-scanning as the primary diagnostic tool to demonstrate the presence of an adrenocortical carcinoma (ACC). However, prospective data describing the diagnostic yield and cost-effectiveness of repeat CT-scanning are limited. SERENDIPITY represents the largest prospective study on AI management thus far and aims to improve the cost-effectiveness of the diagnostic strategy by the application of a
single baseline urinary steroid profiling (USP). In retrospective studies, it has been shown that USP distinguishes benign AI from ACC with high
sensitivity and high specificity. If these promising results are to be confirmed in our study, then USP would offer a safe, patient-friendly and inexpensive alternative to repeat CT- scanning. In addition, we aim to examine the psychological impact for patients with AI being currently subjected to repeated laboratory tests and CT-scanning during several years.
Doel van het onderzoek
We hypothesize that urinary steroid profiling is cost-effective compared to repeat CT-scanning in patients with adrenal incidentalomas.
Onderzoeksopzet
•December 2014 – June, 2016: patient recruitment.
•December, 2014 – June, 2018: patient evaluation according to study algorithm, data collection and data entry.
•June, 2018 – December, 2018: data analysis and reporting.
Onderzoeksproduct en/of interventie
Not applicable.
This is not an interventional study per se, as patients with an adrenal incidentaloma are evaluated according to current management guidelines.
The diagnostic value of urinary steroid profiling will be assessed at the end of the study. Thus, the results of urinary steroid profiling will not affect the clinical management of participants with adrenal incidentaloma.
Algemeen / deelnemers
University Medical Center Groningen
M.N. Kerstens
Groningen
The Netherlands
+31 (0)50 3616161/3518
m.n.kerstens@umcg.nl
Wetenschappers
University Medical Center Groningen
M.N. Kerstens
Groningen
The Netherlands
+31 (0)50 3616161/3518
m.n.kerstens@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- adrenal mass > 1 cm in diameter incidentally discovered during CT-scanning, performed for reasons other than an evaluation for adrenal disease
- age 18 years or older
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- extra-adrenal malignancy (i.e. active or past medical history of malignancy, except
for basal cell carcinoma)
- radiologic diagnosis of simple cyst or bilateral adrenal masses
- allergy to radiocontrast
- renal insufficiency (i.e. eGFR <30 /min/1.73m2)
- pregnancy
- inability to understand written Dutch
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL4656 |
NTR-old | NTR4799 |
Ander register | 837002503 : ZonMw project number |