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

• Conditions: Adrenal Incidentaloma; Adrenocortical Carcinoma

• Registration Number: NCT02324647
• Lead Sponsor: University Medical Center Groningen

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.

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.

Study Timeline

• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-24
• Study Start: 2015-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cost-effectiveness	2 years	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

Secondary Outcome Measures

Name	Time	Method
frequency of ACC among patients with AI at baseline or during follow-up	2 years
distribution of pathologic diagnosis in surgically removed adrenal glands	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
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
conversion rate from non-functioning AI towards a hypersecreting AI during follow-up	2 years
costs of diagnostic procedures and surgical interventions	2 years

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands