NCT02324647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
807

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 7, 2026

Status Verified

June 1, 2023

Enrollment Period

8.4 years

First QC Date

December 19, 2014

Last Update Submit

January 5, 2026

Conditions

Adrenal IncidentalomaAdrenocortical Carcinoma

Keywords

Urinary steroid profilingAdrenal incidentalomaAdrenocortical carcinomacost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

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

    2 years

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

    2 years

  • distribution of pathologic diagnosis in surgically removed adrenal glands

    2 years

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

    2 years

  • frequency distribution between hormonal hypersecreting and non-functional AI

    2 years

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

Related Publications (13)

  • 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.

    PMID: 12614096BACKGROUND

  • 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.

    PMID: 17287480BACKGROUND

  • 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.

    PMID: 16172193BACKGROUND

  • 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.

    PMID: 10732265BACKGROUND

  • 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.

    PMID: 19439510BACKGROUND

  • 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.

    PMID: 19755599BACKGROUND

  • 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.

    PMID: 10399855BACKGROUND

  • 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.

    PMID: 2141212BACKGROUND

  • 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.

    PMID: 9597936BACKGROUND

  • 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.

    PMID: 10915023BACKGROUND

  • 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.

    PMID: 4017973BACKGROUND

  • 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.

    PMID: 11939242BACKGROUND

  • 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.

    PMID: 22863384BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples and serum or plasma samples

MeSH Terms

Conditions

Adrenal incidentalomaAdrenocortical Carcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteAdrenal Cortex DiseasesAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Michiel N Kerstens, MD, PhD

    University Medical Center Groningen

    STUDY DIRECTOR

  • E Buitenwerf, MD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

  • P.H.L.T. Bisschop, MD, PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

  • E.M.W. Eekhoff, MD, PhD

    Free University UMC Amsterdam

    PRINCIPAL INVESTIGATOR

  • E.P.M. van der Kleij-Corssmit, MD, PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

  • R.A. Feelders, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • B. Havekes, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • H.J.L.M Timmers, MD, PhD

    UMC St Radboud Nijmegen

    PRINCIPAL INVESTIGATOR

  • G.D. Valk, MD, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • P.H.N. Oomen, MD, PhD

    medical center leeuwarden

    PRINCIPAL INVESTIGATOR

  • K.M. van Tol, MD, PhD

    Martini Hospital Groningen

    PRINCIPAL INVESTIGATOR

  • R.S.M.E. Wouters, MD

    Scheper Hospital

    PRINCIPAL INVESTIGATOR

  • A.A.M. Franken, MD, PhD

    Isala

    PRINCIPAL INVESTIGATOR

  • J.R. Meinardi, MD, PhD

    Canisius-Wilhelmina Hospital

    PRINCIPAL INVESTIGATOR

  • R. GrooteVeldman, MD, PhD

    Medisch Spectrum Twente

    PRINCIPAL INVESTIGATOR

  • P.C. Oldenburg-Ligtenberg, MD, PhD

    Meander Medical Center

    PRINCIPAL INVESTIGATOR

  • A.F. Muller, MD, PhD

    Diakonessenhuis, Utrecht

    PRINCIPAL INVESTIGATOR

  • M.O. van Aken, MD, PhD

    Haga Hospital

    PRINCIPAL INVESTIGATOR

  • W. de Ronde, MD, PhD

    Kennemer Gasthuis

    PRINCIPAL INVESTIGATOR

  • H.R. Haak, MD, PhD

    Maxima Medical Center

    PRINCIPAL INVESTIGATOR

  • S. Simsek, MD, PhD

    Medical Center Alkmaar

    PRINCIPAL INVESTIGATOR

  • I.M.M.J. Wakelkamp, MD, PhD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

  • I.I.L. Berk-Planken, MD, PhD

    Vlietland Ziekenhuis

    PRINCIPAL INVESTIGATOR

  • P.S. van Dam, MD, PhD

    Onze Lieve Vrouwe Gasthuis

    PRINCIPAL INVESTIGATOR

  • H. de Boer, MD, PhD

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

  • J.J.J. de Sonnaville, MD, PhD

    Tergooi Hospital

    PRINCIPAL INVESTIGATOR

  • E. Donga, MD

    St.Elisabeth Hospital

    PRINCIPAL INVESTIGATOR

  • N. Smit, MD

    Flevoland Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

December 24, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

January 7, 2026

Record last verified: 2023-06

Locations

NL(1)