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

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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