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Structured evaluation of adrenal gland tumors found incidentally during imaging studies.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22990
Enrollment
1000
Registered
2014-09-21
Start date
2014-12-26
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adrenal incidentaloma adrenocortical carcinoma urinary steroid profiling

Interventions

Not applicable. This is not an interventional study per se, as patients with an adrenal incidentaloma are evaluated according to current management guidelines. The diagnostic value of urinary stero

Sponsors

University Medical Center Groningen Amsterdam Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - adrenal mass > 1 cm in diameter incidentally discovered during CT-scanning, performed for reasons other than an evaluation for adrenal disease - age 18 years or older

Exclusion criteria

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 /min/1.73m2) - pregnancy - inability to understand written Dutch

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter is the difference in cost-effectiveness of the current management strategy based on repeat CT-scanning to detect adrenocortical carcinoma among patients with an adrenal incidentaloma compared with a strategy using a single baseline urinary steroid profiling.

Secondary

MeasureTime frame
• frequency of adrenocortical carcinoma among patients with an adrenal incidentaloma at baseline or during follow-up. • determination of the percentage of adrenal incidentaloma that fulfils the criteria of a malignant CT-phenotype at baseline or during follow-up. • determination of the pathologic diagnosis in patients who underwent adrenalectomy. • QoL in patients with an adrenal incidentaloma at baseline and during follow-up. • frequency distribution between hormonal hypersecreting and non-functional adrenal incidentaloma. • conversion rate of a non-functioning adrenal incidentaloma towards a hypersecreting adrenal incidentaloma during follow-up. • costs of diagnostic procedures and surgical interventions.

Contacts

Public ContactM.N. Kerstens

Department of Endocrinology University Medical Center Groningen

m.n.kerstens@umcg.nl+31 (0)50 3616161/3518

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)