Clinical trial NCT02324647: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adrenal Incidentaloma
Adrenocortical Carcinoma
Keywords: Urinary steroid profiling
Adrenal incidentaloma
Adrenocortical carcinoma
cost-effectiveness
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Amsterdam UMC, location VUmc
name: Radboud University Medical Center
name: Leiden University Medical Center
name: Maastricht University Medical Center
name: UMC Utrecht
name: Erasmus Medical Center
name: Martini Hospital Groningen
name: Canisius-Wilhelmina Hospital
name: Diakonessenhuis, Utrecht
name: Isala
name: Haga Hospital
name: St. Antonius Hospital
name: Kennemer Gasthuis
name: Maxima Medical Center
name: Medical Center Alkmaar
name: Frisius Medisch Centrum
name: Meander Medical Center
name: Medisch Spectrum Twente
name: Onze Lieve Vrouwe Gasthuis
name: Rijnstate Hospital
name: Elisabeth-TweeSteden Ziekenhuis
name: Tergooi Hospital
name: Vlietland Ziekenhuis
name: Scheper Hospital
name: Flevo Hospital
First posted: 2014-12-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The research population consists of adult patients with a recently discovered adrenal incidentaloma who meet the selection criteria of SERENDIPITY. A total number of 1000 patients will be included. These subjects will be recruited from the group of patients in whom CT/MRI-scanning has been performed with visualization of the adrenal glands (i.e. CT/MRI scans of abdomen and/or chest, as the latter often include imaging of the upper abdominal region).

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 criteria: 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.

Primary outcomes:
measure: Cost-effectiveness
timeFrame: 2 years
Secondary outcomes:
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: 2 years
measure: QoL in patients with an AI at baseline and during follow-up
timeFrame: 2 years
measure: frequency distribution between hormonal hypersecreting and non-functional AI
timeFrame: 2 years
measure: conversion rate from non-functioning AI towards a hypersecreting AI during follow-up
timeFrame: 2 years
measure: costs of diagnostic procedures and surgical interventions
timeFrame: 2 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Michiel N Kerstens, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Medical Center Groningen
name: E Buitenwerf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location VUmc
name: P.H.L.T. Bisschop, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Free University UMC Amsterdam
name: E.M.W. Eekhoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Center
name: E.P.M. van der Kleij-Corssmit, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: R.A. Feelders, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: B. Havekes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC St Radboud Nijmegen
name: H.J.L.M Timmers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: G.D. Valk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: medical center leeuwarden
name: P.H.N. Oomen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Martini Hospital Groningen
name: K.M. van Tol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scheper Hospital
name: R.S.M.E. Wouters, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Isala
name: A.A.M. Franken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canisius-Wilhelmina Hospital
name: J.R. Meinardi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medisch Spectrum Twente
name: R. GrooteVeldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meander Medical Center
name: P.C. Oldenburg-Ligtenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diakonessenhuis, Utrecht
name: A.F. Muller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haga Hospital
name: M.O. van Aken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kennemer Gasthuis
name: W. de Ronde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maxima Medical Center
name: H.R. Haak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Center Alkmaar
name: S. Simsek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: I.M.M.J. Wakelkamp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vlietland Ziekenhuis
name: I.I.L. Berk-Planken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Onze Lieve Vrouwe Gasthuis
name: P.S. van Dam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rijnstate Hospital
name: H. de Boer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tergooi Hospital
name: J.J.J. de Sonnaville, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St.Elisabeth Hospital
name: E. Donga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Flevoland Hospital
name: N. Smit, MD
role: PRINCIPAL_INVESTIGATOR
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