|- candidate number||19521|
|- NTR Number||NTR4799|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-sep-2014|
|- Secondary IDs||ZonMw project number 837002503|
|- Public Title||Structured evaluation of adrenal gland tumors found incidentally during imaging studies.|
|- Scientific Title||Structured Evaluation of adRENal tumors Discovered Incidentally - Prospectively Investigating the Testing Yield.|
|- hypothesis||We hypothesize that urinary steroid profiling is cost-effective compared to repeat CT-scanning in patients with adrenal incidentalomas.|
|- Healt Condition(s) or Problem(s) studied||Adrenal gland tumor |
|- Inclusion criteria||- 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
|- Exclusion criteria||- 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)
- inability to understand written Dutch
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||26-dec-2014|
|- planned closingdate||26-dec-2018|
|- Target number of participants||1000|
|- Interventions||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.
|- Primary outcome||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.|
|- Secondary outcome||• frequency of adrenocortical carcinoma among patients with an adrenal incidentaloma at baseline or during follow-up.
• determination of the percentage of adrenal incidentaloma that fulfils the criteria of a malignant CT-phenotype at baseline or during follow-up.
• determination of the pathologic diagnosis in patients who underwent adrenalectomy.
• QoL in patients with an adrenal incidentaloma at baseline and during follow-up.
• frequency distribution between hormonal hypersecreting and non-functional adrenal incidentaloma.
• conversion rate of a non-functioning adrenal incidentaloma towards a hypersecreting adrenal incidentaloma during follow-up.
• costs of diagnostic procedures and surgical interventions.
|- Timepoints||•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.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. M.N. Kerstens|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. M.N. Kerstens|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||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.|
|- Main changes (audit trail)|
|- RECORD||21-sep-2014 - 15-okt-2014|