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Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield

Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adrenal Incidentaloma; Adrenocortical Carcinoma

Phase: N/A

Status: Recruiting

Sponsored by: University Medical Center Groningen

Official(s) and/or principal investigator(s):
Michiel N Kerstens, MD, PhD, Study Director, Affiliation: University Medical Center Groningen
E Buitenwerf, MD, Principal Investigator, Affiliation: University Medical Center Groningen
P.H.L.T. Bisschop, MD, PhD, Principal Investigator, Affiliation: Amsterdam Medical Center
E.M.W. Eekhoff, MD, PhD, Principal Investigator, Affiliation: Free University UMC Amsterdam
E.P.M. van der Kleij-Corssmit, MD, PhD, Principal Investigator, Affiliation: Leiden University Medical Center
R.A. Feelders, MD, PhD, Principal Investigator, Affiliation: Erasmus Medical Center Rotterdam
B. Havekes, MD, PhD, Principal Investigator, Affiliation: Maastricht University Medical Center
H.J.L.M Timmers, MD, PhD, Principal Investigator, Affiliation: UMC St Radboud Nijmegen
G.D. Valk, MD, PhD, Principal Investigator, Affiliation: UMC Utrecht
P.H.N. Oomen, MD, PhD, Principal Investigator, Affiliation: Medical Center Leeuwarden
K.M. van Tol, MD, PhD, Principal Investigator, Affiliation: Martini Hospital Groningen
R.S.M.E. Wouters, MD, Principal Investigator, Affiliation: Scheper Hospital
A.A.M. Franken, MD, PhD, Principal Investigator, Affiliation: Isala
J.R. Meinardi, MD, PhD, Principal Investigator, Affiliation: Canisius-Wilhelmina Hospital
R. GrooteVeldman, MD, PhD, Principal Investigator, Affiliation: Medisch Spectrum Twente
P.C. Oldenburg-Ligtenberg, MD, PhD, Principal Investigator, Affiliation: Meander Medical Center
A.F. Muller, MD, PhD, Principal Investigator, Affiliation: Diakonessenhuis, Utrecht
M.O. van Aken, MD, PhD, Principal Investigator, Affiliation: Haga Hospital
W. de Ronde, MD, PhD, Principal Investigator, Affiliation: Kennemer Gasthuis
H.R. Haak, MD, PhD, Principal Investigator, Affiliation: Máxima Medical Center
S. Simsek, MD, PhD, Principal Investigator, Affiliation: Medical Center Alkmaar
I.M.M.J. Wakelkamp, MD, PhD, Principal Investigator, Affiliation: St. Antonius Hospital
I.I.L. Berk-Planken, MD, PhD, Principal Investigator, Affiliation: Vlietland Hospital
P.S. van Dam, MD, PhD, Principal Investigator, Affiliation: Onze Lieve Vrouwe Gasthuis
H. de Boer, MD, PhD, Principal Investigator, Affiliation: Rijnstate Hospital
J.J.J. de Sonnaville, MD, PhD, Principal Investigator, Affiliation: Tergooi Hospital
E. Donga, MD, Principal Investigator, Affiliation: St.Elisabeth Hospital
N. Smit, MD, Principal Investigator, Affiliation: Flevoland Hospital

Overall contact:
Michiel N Kerstens, MD, PhD, Phone: 0031-503613518, Email: m.n.kerstens@umcg.nl

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.

Clinical Details

Official title: Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Cost-effectiveness

Secondary outcome:

frequency of ACC among patients with AI at baseline or during follow-up

determination of the percentage of AI that meets the criteria of a malignant CT- phenotype at baseline or during follow-up

distribution of pathologic diagnosis in surgically removed adrenal glands

QoL in patients with an AI at baseline and during follow-up

frequency distribution between hormonal hypersecreting and non-functional AI

conversion rate from non-functioning AI towards a hypersecreting AI during follow-up

costs of diagnostic procedures and surgical interventions

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. Maximum age: N/A. Gender(s): Both.

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

- 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

- inability to understand written Dutch.

Locations and Contacts

Michiel N Kerstens, MD, PhD, Phone: 0031-503613518, Email: m.n.kerstens@umcg.nl

University Medical Center Groningen, Groningen 9700 RB, Netherlands; Recruiting
M N Kerstens, MD, PhD, Phone: 0031-503613518, Email: m.n.kerstens@umcg.nl
Additional Information

Related publications:

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.

Young WF Jr. Clinical practice. The incidentally discovered adrenal mass. N Engl J Med. 2007 Feb 8;356(6):601-10. Review.

Nawar R, Aron D. Adrenal incidentalomas -- a continuing management dilemma. Endocr Relat Cancer. 2005 Sep;12(3):585-98. Review.

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. Review.

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. Review.

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. Review.

Gröndal S, Eriksson B, Hagenäs 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.

Khorram-Manesh A, Ahlman H, Jansson S, Wängberg 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.

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.

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.

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.

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. Review.

Starting date: January 2015
Last updated: February 8, 2015

Page last updated: August 20, 2015

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