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

Adrenocortical Carcinoma Clinical Trial

— SERENDIPITY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02324647
• Other study ID #: UGroningen
• Secondary ID: 4799
• Status: Recruiting
• Start date: January 2015
• Est. completion date: November 2022

Study information

• Verified date: September 2021
• Source: University Medical Center Groningen
• Contact: Michiel N Kerstens, MD, PhD
• Phone: 0031-503613518
• Email: m.n.kerstens[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenal Incidentaloma
• Adrenocortical Adenoma
• Adrenocortical Carcinoma

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (27)

Lead Sponsor

Collaborator

University Medical Center Groningen

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Canisius-Wilhelmina Hospital, Diakonessenhuis, Utrecht, Elisabeth-TweeSteden Ziekenhuis, Erasmus Medical Center, Flevo Hospital, Haga Hospital, Isala, Kennemer Gasthuis, Leiden University Medical Center, Maastricht University Medical Center, Martini Hospital Groningen, Maxima Medical Center, Meander Medical Center, Medical Center Alkmaar, Medical Centre Leeuwarden, Medisch Spectrum Twente, Onze Lieve Vrouwe Gasthuis, Radboud University, Rijnstate Hospital, Scheper Hospital, St. Antonius Hospital, Tergooi Hospital, UMC Utrecht, Vlietland Ziekenhuis, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-effectiveness	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	2 years
Secondary	frequency of ACC among patients with AI at baseline or during follow-up		2 years
Secondary	determination of the percentage of AI that meets the criteria of a malignant CT- phenotype at baseline or during follow-up		2 years
Secondary	distribution of pathologic diagnosis in surgically removed adrenal glands		2 years
Secondary	QoL in patients with an AI at baseline and during follow-up		2 years
Secondary	frequency distribution between hormonal hypersecreting and non-functional AI		2 years
Secondary	conversion rate from non-functioning AI towards a hypersecreting AI during follow-up		2 years
Secondary	costs of diagnostic procedures and surgical interventions		2 years