Clinical trial · Observational
Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
NCT02324647CI-TRIAL-00100271SERENDIPITYcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Standard diagnostic work-up for adrenal incidentalomas (AI) consists of periodical biochemical analysis and CT-scanning in case the initial work-up does not demonstrate the presence of hormonal hypersecretion or adrenocortical carcinoma (ACC), respectively. The overall aim of this study is to improve the cost-effectiveness of the diagnostic strategy for AI. Cost-effectiveness of urine steroid profiling (USP) will be compared to the standard diagnostic strategy of repeated CT-imaging.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Incidentaloma | — | UNRESOLVED | — |
| Adrenocortical Carcinoma | Adrenal Cortical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Cost-effectiveness
- timeFrame
- 2 years
- description
- difference in cost-effectiveness of the current management strategy based on repeat CT-scanning to detect ACC among patients with an AI compared with a strategy using a single baseline USP
Secondary outcomes (7)
- measure
- frequency of ACC among patients with AI at baseline or during follow-up
- timeFrame
- 2 years
- measure
- determination of the percentage of AI that meets the criteria of a malignant CT- phenotype at baseline or during follow-up
- timeFrame
- 2 years
- measure
- distribution of pathologic diagnosis in surgically removed adrenal glands
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * discrete adrenal mass \> 1 cm in diameter incidentally discovered during CT/MRI-scanning, performed for reasons other than an evaluation for adrenal disease * detection CT/MRI-scan performed ≤ 4 months ago * 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 ml/min/1.73m2) * pregnancy * adrenal incidentaloma visible on previous (i.e. \> 4 months ago) CT/MRI-scan * inability to understand written Dutch.
References
Publications (13)
- BACKGROUNDGrumbach MM, Biller BM, Braunstein GD, Campbell KK, Carney JA, Godley PA, Harris EL, Lee JK, Oertel YC, Posner MC, Schlechte JA, Wieand HS. Management of the clinically inapparent adrenal mass ("incidentaloma"). Ann Intern Med. 2003 Mar 4;138(5):424-9. doi: 10.7326/0003-4819-138-5-200303040-00013. PMID 12614096
- BACKGROUNDYoung WF Jr. Clinical practice. The incidentally discovered adrenal mass. N Engl J Med. 2007 Feb 8;356(6):601-10. doi: 10.1056/NEJMcp065470. No abstract available. PMID 17287480
- BACKGROUNDNawar R, Aron D. Adrenal incidentalomas -- a continuing management dilemma. Endocr Relat Cancer. 2005 Sep;12(3):585-98. doi: 10.1677/erc.1.00951. PMID 16172193
- BACKGROUNDKievit J, Haak HR. Diagnosis and treatment of adrenal incidentaloma. A cost-effectiveness analysis. Endocrinol Metab Clin North Am. 2000 Mar;29(1):69-90, viii-ix. doi: 10.1016/s0889-8529(05)70117-1. PMID 10732265
- BACKGROUNDCawood TJ, Hunt PJ, O'Shea D, Cole D, Soule S. Recommended evaluation of adrenal incidentalomas is costly, has high false-positive rates and confers a risk of fatal cancer that is similar to the risk of the adrenal lesion becoming malignant; time for a rethink? Eur J Endocrinol. 2009 Oct;161(4):513-27. doi: 10.1530/EJE-09-0234. Epub 2009 May 13. PMID 19439510
- BACKGROUNDJohnson PT, Horton KM, Fishman EK. Adrenal mass imaging with multidetector CT: pathologic conditions, pearls, and pitfalls. Radiographics. 2009 Sep-Oct;29(5):1333-51. doi: 10.1148/rg.295095027. PMID 19755599
- BACKGROUNDWolthers BG, Kraan GP. Clinical applications of gas chromatography and gas chromatography-mass spectrometry of steroids. J Chromatogr A. 1999 May 28;843(1-2):247-74. doi: 10.1016/s0021-9673(99)00153-3. PMID 10399855