Brief Title
Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
Official Title
Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
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 Type
Observational [Patient Registry]
Primary Outcome
Cost-effectiveness
Secondary Outcome
frequency of ACC among patients with AI at baseline or during follow-up
Condition
Adrenal Incidentaloma
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1000
Start Date
January 2015
Completion Date
June 2020
Primary Completion Date
March 2020
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Michiel N Kerstens, MD, PhD, 0031-503613518, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT02324647
Organization ID
UGroningen
Secondary IDs
4799
Responsible Party
Principal Investigator
Study Sponsor
University Medical Center Groningen
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor
Michiel N Kerstens, MD, PhD, Study Director, University Medical Center Groningen
Verification Date
June 2019