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Trial record 30 of 67 for:    "Adrenocortical carcinoma"

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

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ClinicalTrials.gov Identifier: NCT02324647
Recruitment Status : Recruiting
First Posted : December 24, 2014
Last Update Posted : June 21, 2017
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
VU University Medical Center
Radboud University
Leiden University Medical Center
Maastricht University Medical Center
UMC Utrecht
Erasmus Medical Center
Martini Hospital Groningen
Canisius-Wilhelmina Hospital
Diakonessenhuis, Utrecht
Isala
Haga Hospital
St. Antonius Hospital
Kennemer Gasthuis
Maxima Medical Center
Medical Center Alkmaar
Medical Centre Leeuwarden
Meander Medical Center
Medisch Spectrum Twente
Onze Lieve Vrouwe Gasthuis
Rijnstate Hospital
Elisabeth-TweeSteden Ziekenhuis
Tergooi Hospital
Vlietland Ziekenhuis
Scheper Hospital
Flevo Hospital
Information provided by (Responsible Party):
Michiel N. Kerstens, 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.

Condition or disease
Adrenal Incidentaloma Adrenocortical Carcinoma

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]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
Study Start Date : January 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019





Primary Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 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 :
  1. frequency of ACC among patients with AI at baseline or during follow-up [ Time Frame: 2 years ]
  2. determination of the percentage of AI that meets the criteria of a malignant CT- phenotype at baseline or during follow-up [ Time Frame: 2 years ]
  3. distribution of pathologic diagnosis in surgically removed adrenal glands [ Time Frame: 2 years ]
  4. QoL in patients with an AI at baseline and during follow-up [ Time Frame: 2 years ]
  5. frequency distribution between hormonal hypersecreting and non-functional AI [ Time Frame: 2 years ]
  6. conversion rate from non-functioning AI towards a hypersecreting AI during follow-up [ Time Frame: 2 years ]
  7. costs of diagnostic procedures and surgical interventions [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Urine samples and serum or plasma samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The research population consists of adult patients with a recently discovered adrenal incidentaloma who meet the selection criteria of SERENDIPITY. A total number of 1000 patients will be included. These subjects will be recruited from the group of patients in whom CT/MRI-scanning has been performed with visualization of the adrenal glands (i.e. CT/MRI scans of abdomen and/or chest, as the latter often include imaging of the upper abdominal region).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324647


Contacts
Contact: Michiel N Kerstens, MD, PhD 0031-503613518 m.n.kerstens@umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: M N Kerstens, MD, PhD    0031-503613518    m.n.kerstens@umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
VU University Medical Center
Radboud University
Leiden University Medical Center
Maastricht University Medical Center
UMC Utrecht
Erasmus Medical Center
Martini Hospital Groningen
Canisius-Wilhelmina Hospital
Diakonessenhuis, Utrecht
Isala
Haga Hospital
St. Antonius Hospital
Kennemer Gasthuis
Maxima Medical Center
Medical Center Alkmaar
Medical Centre Leeuwarden
Meander Medical Center
Medisch Spectrum Twente
Onze Lieve Vrouwe Gasthuis
Rijnstate Hospital
Elisabeth-TweeSteden Ziekenhuis
Tergooi Hospital
Vlietland Ziekenhuis
Scheper Hospital
Flevo Hospital
Investigators
Study Director: Michiel N Kerstens, MD, PhD University Medical Center Groningen
Principal Investigator: E Buitenwerf, MD University Medical Center Groningen
Principal Investigator: P.H.L.T. Bisschop, MD, PhD Amsterdam Medical Center
Principal Investigator: E.M.W. Eekhoff, MD, PhD Free University UMC Amsterdam
Principal Investigator: E.P.M. van der Kleij-Corssmit, MD, PhD Leiden University Medical Center
Principal Investigator: R.A. Feelders, MD, PhD Erasmus Medical Center
Principal Investigator: B. Havekes, MD, PhD Maastricht University Medical Center
Principal Investigator: H.J.L.M Timmers, MD, PhD UMC St Radboud Nijmegen
Principal Investigator: G.D. Valk, MD, PhD UMC Utrecht
Principal Investigator: P.H.N. Oomen, MD, PhD Medical Center Leeuwarden
Principal Investigator: K.M. van Tol, MD, PhD Martini Hospital Groningen
Principal Investigator: R.S.M.E. Wouters, MD Scheper Hospital
Principal Investigator: A.A.M. Franken, MD, PhD Isala
Principal Investigator: J.R. Meinardi, MD, PhD Canisius-Wilhelmina Hospital
Principal Investigator: R. GrooteVeldman, MD, PhD Medisch Spectrum Twente
Principal Investigator: P.C. Oldenburg-Ligtenberg, MD, PhD Meander Medical Center
Principal Investigator: A.F. Muller, MD, PhD Diakonessenhuis, Utrecht
Principal Investigator: M.O. van Aken, MD, PhD Haga Hospital
Principal Investigator: W. de Ronde, MD, PhD Kennemer Gasthuis
Principal Investigator: H.R. Haak, MD, PhD Máxima Medical Center
Principal Investigator: S. Simsek, MD, PhD Medical Center Alkmaar
Principal Investigator: I.M.M.J. Wakelkamp, MD, PhD St. Antonius Hospital
Principal Investigator: I.I.L. Berk-Planken, MD, PhD Vlietland Ziekenhuis
Principal Investigator: P.S. van Dam, MD, PhD Onze Lieve Vrouwe Gasthuis
Principal Investigator: H. de Boer, MD, PhD Rijnstate Hospital
Principal Investigator: J.J.J. de Sonnaville, MD, PhD Tergooi Hospital
Principal Investigator: E. Donga, MD St.Elisabeth Hospital
Principal Investigator: N. Smit, MD Flevoland Hospital

Publications:

Responsible Party: Michiel N. Kerstens, MD, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02324647     History of Changes
Other Study ID Numbers: UGroningen
4799 ( Registry Identifier: Nederlands Trial Register )
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

Keywords provided by Michiel N. Kerstens, University Medical Center Groningen:
Urinary steroid profiling
Adrenal incidentaloma
Adrenocortical carcinoma
cost-effectiveness

Additional relevant MeSH terms:
Adrenocortical Carcinoma
Adrenal Gland Neoplasms
Adrenocortical Adenoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenal Cortex Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics