CompletedNot Applicable

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

Netherlands807 participantsStarted 2015-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cost-effectiveness

Timeframe: 2 years

Trial details

NCT IDNCT02324647

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06

View on ClinicalTrials.gov More Adrenal Incidentaloma trials