Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
NCT ID: NCT02324647
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
807 participants
OBSERVATIONAL
2015-01-31
2023-06-30
Brief Summary
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Detailed Description
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Objective: SERENDIPITY aims to improve the cost-effectiveness of the diagnostic strategy for AI by the application of a single baseline USP. 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.
Study design: This is a prospective observational multicenter study. Study population: Patients are eligible if they meet the following inclusion criteria: adrenal mass \> 1 cm in diameter incidentally discovered during CT or MRI-scanning, performed for reasons other than an evaluation for adrenal disease and age 18 years or older. The exclusion criteria are: 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 or inability to understand written Dutch.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* detection CT/MRI-scan performed ≤ 4 months ago
* age 18 years or older.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Amsterdam UMC, location VUmc
OTHER
Radboud University Medical Center
OTHER
Leiden University Medical Center
OTHER
Maastricht University Medical Center
OTHER
UMC Utrecht
OTHER
Erasmus Medical Center
OTHER
Martini Hospital Groningen
OTHER
Canisius-Wilhelmina Hospital
OTHER
Diakonessenhuis, Utrecht
OTHER
Isala
OTHER
Haga Hospital
OTHER
St. Antonius Hospital
OTHER
Kennemer Gasthuis
OTHER
Maxima Medical Center
OTHER
Medical Center Alkmaar
OTHER
Frisius Medisch Centrum
OTHER
Meander Medical Center
OTHER
Medisch Spectrum Twente
OTHER
Onze Lieve Vrouwe Gasthuis
OTHER
Rijnstate Hospital
OTHER
Elisabeth-TweeSteden Ziekenhuis
OTHER
Tergooi Hospital
OTHER
Vlietland Ziekenhuis
OTHER
Treant ziekenhuis
UNKNOWN
Flevoziekenhuis
OTHER
University Medical Center Groningen
OTHER
Responsible Party
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Principal Investigators
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Michiel N Kerstens, MD, PhD
Role: STUDY_DIRECTOR
University Medical Center Groningen
E Buitenwerf, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
P.H.L.T. Bisschop, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
E.M.W. Eekhoff, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Free University UMC Amsterdam
E.P.M. van der Kleij-Corssmit, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
R.A. Feelders, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
B. Havekes, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
H.J.L.M Timmers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC St Radboud Nijmegen
G.D. Valk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
P.H.N. Oomen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
medical center leeuwarden
K.M. van Tol, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Martini Hospital Groningen
R.S.M.E. Wouters, MD
Role: PRINCIPAL_INVESTIGATOR
Scheper Hospital
A.A.M. Franken, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Isala
J.R. Meinardi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Canisius-Wilhelmina Hospital
R. GrooteVeldman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medisch Spectrum Twente
P.C. Oldenburg-Ligtenberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Meander Medical Center
A.F. Muller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Diakonessenhuis, Utrecht
M.O. van Aken, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Haga Hospital
W. de Ronde, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kennemer Gasthuis
H.R. Haak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maxima Medical Center
S. Simsek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical Center Alkmaar
I.M.M.J. Wakelkamp, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Antonius Hospital
I.I.L. Berk-Planken, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vlietland Ziekenhuis
P.S. van Dam, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Onze Lieve Vrouwe Gasthuis
H. de Boer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Rijnstate Hospital
J.J.J. de Sonnaville, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tergooi Hospital
E. Donga, MD
Role: PRINCIPAL_INVESTIGATOR
St.Elisabeth Hospital
N. Smit, MD
Role: PRINCIPAL_INVESTIGATOR
Flevoland Hospital
Locations
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University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
Countries
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References
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Kievit 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.
Nawar R, Aron D. Adrenal incidentalomas -- a continuing management dilemma. Endocr Relat Cancer. 2005 Sep;12(3):585-98. doi: 10.1677/erc.1.00951.
Grumbach 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.
Young 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.
Cawood 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.
Johnson 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.
Wolthers 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.
Grondal S, Eriksson B, Hagenas L, Werner S, Curstedt T. Steroid profile in urine: a useful tool in the diagnosis and follow up of adrenocortical carcinoma. Acta Endocrinol (Copenh). 1990 May;122(5):656-63. doi: 10.1530/acta.0.1220656.
Khorram-Manesh A, Ahlman H, Jansson S, Wangberg B, Nilsson O, Jakobsson CE, Eliasson B, Lindstedt S, Tisell LE. Adrenocortical carcinoma: surgery and mitotane for treatment and steroid profiles for follow-up. World J Surg. 1998 Jun;22(6):605-11; discussion 611-2. doi: 10.1007/s002689900442.
Kikuchi E, Yanaihara H, Nakashima J, Homma K, Ohigashi T, Asakura H, Tachibana M, Shibata H, Saruta T, Murai M. Urinary steroid profile in adrenocortical tumors. Biomed Pharmacother. 2000 Jun;54 Suppl 1:194s-197s. doi: 10.1016/s0753-3322(00)80043-8.
Minowada S, Kinoshita K, Hara M, Isurugi K, Uchikawa T, Niijima T. Measurement of urinary steroid profile in patients with adrenal tumor as a screening method for carcinoma. Endocrinol Jpn. 1985 Feb;32(1):29-37. doi: 10.1507/endocrj1954.32.29.
Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002 Mar;21(2):271-92. doi: 10.1016/s0167-6296(01)00130-8.
Arnaldi G, Boscaro M. Adrenal incidentaloma. Best Pract Res Clin Endocrinol Metab. 2012 Aug;26(4):405-19. doi: 10.1016/j.beem.2011.12.006. Epub 2012 May 22.
Other Identifiers
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4799
Identifier Type: REGISTRY
Identifier Source: secondary_id
UGroningen
Identifier Type: -
Identifier Source: org_study_id
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