Spots Global Cancer Trial Database for Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
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Trial Identification
Brief Title: Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
Official Title: Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
Study ID: NCT02324647
Interventions
Study Description
Brief Summary: 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.
Detailed Description: Rationale: 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. With respect to the diagnosis of ACC, the health benefits of this strategy are controversial for the following reasons: a. critical appraisal of literature has revealed a much lower ACC frequency of 1.9% than previously presumed; b. CT sensitivity and specificity are suboptimal; c. risk of unnecessary adrenalectomies; d. exposure to ionising radiation; e. risk of CT contrast reactions (nephropathy, allergic reaction); f. health care related and economical costs. The hypothesis to be tested is that incorporation of a single baseline urinary steroid profiling (USP) into the management algorithm of AI is more cost-effective than a strategy solely based on repeat CT-scanning. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
University Medical Center Groningen, Groningen, , Netherlands
Contact Details
Name: Michiel N Kerstens, MD, PhD
Affiliation: University Medical Center Groningen
Role: STUDY_DIRECTOR
Name: E Buitenwerf, MD
Affiliation: University Medical Center Groningen
Role: PRINCIPAL_INVESTIGATOR
Name: P.H.L.T. Bisschop, MD, PhD
Affiliation: Amsterdam UMC, location VUmc
Role: PRINCIPAL_INVESTIGATOR
Name: E.M.W. Eekhoff, MD, PhD
Affiliation: Free University UMC Amsterdam
Role: PRINCIPAL_INVESTIGATOR
Name: E.P.M. van der Kleij-Corssmit, MD, PhD
Affiliation: Leiden University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: R.A. Feelders, MD, PhD
Affiliation: Erasmus Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: B. Havekes, MD, PhD
Affiliation: Maastricht University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: H.J.L.M Timmers, MD, PhD
Affiliation: UMC St Radboud Nijmegen
Role: PRINCIPAL_INVESTIGATOR
Name: G.D. Valk, MD, PhD
Affiliation: UMC Utrecht
Role: PRINCIPAL_INVESTIGATOR
Name: P.H.N. Oomen, MD, PhD
Affiliation: Medical Center Leeuwarden
Role: PRINCIPAL_INVESTIGATOR
Name: K.M. van Tol, MD, PhD
Affiliation: Martini Hospital Groningen
Role: PRINCIPAL_INVESTIGATOR
Name: R.S.M.E. Wouters, MD
Affiliation: Scheper Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: A.A.M. Franken, MD, PhD
Affiliation: Isala
Role: PRINCIPAL_INVESTIGATOR
Name: J.R. Meinardi, MD, PhD
Affiliation: Canisius-Wilhelmina Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: R. GrooteVeldman, MD, PhD
Affiliation: Medisch Spectrum Twente
Role: PRINCIPAL_INVESTIGATOR
Name: P.C. Oldenburg-Ligtenberg, MD, PhD
Affiliation: Meander Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: A.F. Muller, MD, PhD
Affiliation: Diakonessenhuis, Utrecht
Role: PRINCIPAL_INVESTIGATOR
Name: M.O. van Aken, MD, PhD
Affiliation: Haga Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: W. de Ronde, MD, PhD
Affiliation: Kennemer Gasthuis
Role: PRINCIPAL_INVESTIGATOR
Name: H.R. Haak, MD, PhD
Affiliation: Máxima Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: S. Simsek, MD, PhD
Affiliation: Medical Center Alkmaar
Role: PRINCIPAL_INVESTIGATOR
Name: I.M.M.J. Wakelkamp, MD, PhD
Affiliation: St. Antonius Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: I.I.L. Berk-Planken, MD, PhD
Affiliation: Vlietland Ziekenhuis
Role: PRINCIPAL_INVESTIGATOR
Name: P.S. van Dam, MD, PhD
Affiliation: Onze Lieve Vrouwe Gasthuis
Role: PRINCIPAL_INVESTIGATOR
Name: H. de Boer, MD, PhD
Affiliation: Rijnstate Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: J.J.J. de Sonnaville, MD, PhD
Affiliation: Tergooi Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: E. Donga, MD
Affiliation: St.Elisabeth Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: N. Smit, MD
Affiliation: Flevoland Hospital
Role: PRINCIPAL_INVESTIGATOR
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