Adrenal IncidentalomaSERENDIPITYNCT02324647
Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
An observational study of Adrenal Incidentaloma and Adrenocortical Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adrenal Incidentaloma, Adrenocortical Carcinoma
- How many people
- 807 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2015to Jun 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9700 RB
About this study
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.
Read the 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.
- Conditions
- Adrenal Incidentaloma, Adrenocortical Carcinoma
- Keywords
- Urinary steroid profiling, Adrenal incidentaloma, Adrenocortical carcinoma, cost-effectiveness
- Medical subject headings
- Adrenal incidentaloma, Adrenocortical Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness
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
Measured: 2 years
Secondary outcomes (7)
frequency of ACC among patients with AI at baseline or during follow-up
Measured: 2 years
determination of the percentage of AI that meets the criteria of a malignant CT- phenotype at baseline or during follow-up
Measured: 2 years
distribution of pathologic diagnosis in surgically removed adrenal glands
Measured: 2 years
QoL in patients with an AI at baseline and during follow-up
Measured: 2 years
frequency distribution between hormonal hypersecreting and non-functional AI
Measured: 2 years
conversion rate from non-functioning AI towards a hypersecreting AI during follow-up
Measured: 2 years
costs of diagnostic procedures and surgical interventions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2023
- Study completionJun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Adrenal IncidentalomaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 807 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amsterdam UMC, location VUmc, Radboud University Medical Center, 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, Frisius Medisch Centrum, Meander Medical Center, Medisch Spectrum Twente, Onze Lieve Vrouwe Gasthuis, Rijnstate Hospital, Elisabeth-TweeSteden Ziekenhuis, Tergooi Hospital, Vlietland Ziekenhuis, Treant ziekenhuis, Flevoziekenhuis
- Responsible party
- Sponsor
- Investigators
- Michiel N Kerstens, MD, PhD, Study director, University Medical Center GroningenE Buitenwerf, MD, Principal investigator, University Medical Center GroningenP.H.L.T. Bisschop, MD, PhD, Principal investigator, Amsterdam UMC, location VUmcE.M.W. Eekhoff, MD, PhD, Principal investigator, Free University UMC AmsterdamE.P.M. van der Kleij-Corssmit, MD, PhD, Principal investigator, Leiden University Medical CenterR.A. Feelders, MD, PhD, Principal investigator, Erasmus Medical CenterB. Havekes, MD, PhD, Principal investigator, Maastricht University Medical CenterH.J.L.M Timmers, MD, PhD, Principal investigator, UMC St Radboud Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324647
- Sponsor's protocol ID
- UGroningen
- Other IDs
- 4799
- Acronym
- SERENDIPITY
- Status last verified
- Jun 2023
- First submitted
- 19 Dec 2014
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
Publications
Grumbach MM, Biller BM, Braunstein GD, Campbell KK, Carney JA, Godley PA, Harris EL, Lee JK, Oertel YC, Posner MC, Schlechte JA, Wieand HS. Management of the clinically inapparent adrenal mass ("incidentaloma"). Ann Intern Med. 2003 Mar 4;138(5):424-9. doi: 10.7326/0003-4819-138-5-200303040-00013.
PubMed 12614096Young WF Jr. Clinical practice. The incidentally discovered adrenal mass. N Engl J Med. 2007 Feb 8;356(6):601-10. doi: 10.1056/NEJMcp065470. No abstract available.
PubMed 17287480Nawar R, Aron D. Adrenal incidentalomas -- a continuing management dilemma. Endocr Relat Cancer. 2005 Sep;12(3):585-98. doi: 10.1677/erc.1.00951.
PubMed 16172193Kievit J, Haak HR. Diagnosis and treatment of adrenal incidentaloma. A cost-effectiveness analysis. Endocrinol Metab Clin North Am. 2000 Mar;29(1):69-90, viii-ix. doi: 10.1016/s0889-8529(05)70117-1.
PubMed 10732265Cawood TJ, Hunt PJ, O'Shea D, Cole D, Soule S. Recommended evaluation of adrenal incidentalomas is costly, has high false-positive rates and confers a risk of fatal cancer that is similar to the risk of the adrenal lesion becoming malignant; time for a rethink? Eur J Endocrinol. 2009 Oct;161(4):513-27. doi: 10.1530/EJE-09-0234. Epub 2009 May 13.
PubMed 19439510Johnson PT, Horton KM, Fishman EK. Adrenal mass imaging with multidetector CT: pathologic conditions, pearls, and pitfalls. Radiographics. 2009 Sep-Oct;29(5):1333-51. doi: 10.1148/rg.295095027.
PubMed 19755599Wolthers BG, Kraan GP. Clinical applications of gas chromatography and gas chromatography-mass spectrometry of steroids. J Chromatogr A. 1999 May 28;843(1-2):247-74. doi: 10.1016/s0021-9673(99)00153-3.
PubMed 10399855Grondal S, Eriksson B, Hagenas L, Werner S, Curstedt T. Steroid profile in urine: a useful tool in the diagnosis and follow up of adrenocortical carcinoma. Acta Endocrinol (Copenh). 1990 May;122(5):656-63. doi: 10.1530/acta.0.1220656.
PubMed 2141212Khorram-Manesh A, Ahlman H, Jansson S, Wangberg B, Nilsson O, Jakobsson CE, Eliasson B, Lindstedt S, Tisell LE. Adrenocortical carcinoma: surgery and mitotane for treatment and steroid profiles for follow-up. World J Surg. 1998 Jun;22(6):605-11; discussion 611-2. doi: 10.1007/s002689900442.
PubMed 9597936Kikuchi E, Yanaihara H, Nakashima J, Homma K, Ohigashi T, Asakura H, Tachibana M, Shibata H, Saruta T, Murai M. Urinary steroid profile in adrenocortical tumors. Biomed Pharmacother. 2000 Jun;54 Suppl 1:194s-197s. doi: 10.1016/s0753-3322(00)80043-8.
PubMed 10915023Minowada S, Kinoshita K, Hara M, Isurugi K, Uchikawa T, Niijima T. Measurement of urinary steroid profile in patients with adrenal tumor as a screening method for carcinoma. Endocrinol Jpn. 1985 Feb;32(1):29-37. doi: 10.1507/endocrj1954.32.29.
PubMed 4017973Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002 Mar;21(2):271-92. doi: 10.1016/s0167-6296(01)00130-8.
PubMed 11939242Arnaldi G, Boscaro M. Adrenal incidentaloma. Best Pract Res Clin Endocrinol Metab. 2012 Aug;26(4):405-19. doi: 10.1016/j.beem.2011.12.006. Epub 2012 May 22.
PubMed 22863384
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
- ClinicalTrials.gov ID
- NCT02324647
- Acronym / sponsor ID
- SERENDIPITY / UGroningen
- Conditions
- Adrenal Incidentaloma, Adrenocortical Carcinoma
- Keywords
- Urinary steroid profiling, Adrenal incidentaloma, Adrenocortical carcinoma, cost-effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 807 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amsterdam UMC, location VUmc, Radboud University Medical Center, 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, Frisius Medisch Centrum, Meander Medical Center, Medisch Spectrum Twente, Onze Lieve Vrouwe Gasthuis, Rijnstate Hospital, Elisabeth-TweeSteden Ziekenhuis, Tergooi Hospital, Vlietland Ziekenhuis, Treant ziekenhuis, Flevoziekenhuis
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2023 (actual)
- Study completion
- Jun 2023 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
frequency of ACC among patients with AI at baseline or during follow-up
Time frame: 2 years
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
distribution of pathologic diagnosis in surgically removed adrenal glands
Time frame: 2 years
QoL in patients with an AI at baseline and during follow-up
Time frame: 2 years
frequency distribution between hormonal hypersecreting and non-functional AI
Time frame: 2 years
conversion rate from non-functioning AI towards a hypersecreting AI during follow-up
Time frame: 2 years
costs of diagnostic procedures and surgical interventions
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 12614096Grumbach MM, Biller BM, Braunstein GD, Campbell KK, Carney JA, Godley PA, Harris EL, Lee JK, Oertel YC, Posner MC, Schlechte JA, Wieand HS. Management of the clinically inapparent adrenal mass ("incidentaloma"). Ann Intern Med. 2003 Mar 4;138(5):424-9. doi: 10.7326/0003-4819-138-5-200303040-00013.
- Background: PubMed 17287480Young WF Jr. Clinical practice. The incidentally discovered adrenal mass. N Engl J Med. 2007 Feb 8;356(6):601-10. doi: 10.1056/NEJMcp065470. No abstract available.
- Background: PubMed 16172193Nawar R, Aron D. Adrenal incidentalomas -- a continuing management dilemma. Endocr Relat Cancer. 2005 Sep;12(3):585-98. doi: 10.1677/erc.1.00951.
- Background: PubMed 10732265Kievit J, Haak HR. Diagnosis and treatment of adrenal incidentaloma. A cost-effectiveness analysis. Endocrinol Metab Clin North Am. 2000 Mar;29(1):69-90, viii-ix. doi: 10.1016/s0889-8529(05)70117-1.
- Background: PubMed 19439510Cawood TJ, Hunt PJ, O'Shea D, Cole D, Soule S. Recommended evaluation of adrenal incidentalomas is costly, has high false-positive rates and confers a risk of fatal cancer that is similar to the risk of the adrenal lesion becoming malignant; time for a rethink? Eur J Endocrinol. 2009 Oct;161(4):513-27. doi: 10.1530/EJE-09-0234. Epub 2009 May 13.
- Background: PubMed 19755599Johnson PT, Horton KM, Fishman EK. Adrenal mass imaging with multidetector CT: pathologic conditions, pearls, and pitfalls. Radiographics. 2009 Sep-Oct;29(5):1333-51. doi: 10.1148/rg.295095027.
- Background: PubMed 10399855Wolthers BG, Kraan GP. Clinical applications of gas chromatography and gas chromatography-mass spectrometry of steroids. J Chromatogr A. 1999 May 28;843(1-2):247-74. doi: 10.1016/s0021-9673(99)00153-3.
- Background: PubMed 2141212Grondal S, Eriksson B, Hagenas L, Werner S, Curstedt T. Steroid profile in urine: a useful tool in the diagnosis and follow up of adrenocortical carcinoma. Acta Endocrinol (Copenh). 1990 May;122(5):656-63. doi: 10.1530/acta.0.1220656.
- Background: PubMed 9597936Khorram-Manesh A, Ahlman H, Jansson S, Wangberg B, Nilsson O, Jakobsson CE, Eliasson B, Lindstedt S, Tisell LE. Adrenocortical carcinoma: surgery and mitotane for treatment and steroid profiles for follow-up. World J Surg. 1998 Jun;22(6):605-11; discussion 611-2. doi: 10.1007/s002689900442.
- Background: PubMed 10915023Kikuchi E, Yanaihara H, Nakashima J, Homma K, Ohigashi T, Asakura H, Tachibana M, Shibata H, Saruta T, Murai M. Urinary steroid profile in adrenocortical tumors. Biomed Pharmacother. 2000 Jun;54 Suppl 1:194s-197s. doi: 10.1016/s0753-3322(00)80043-8.
- Background: PubMed 4017973Minowada S, Kinoshita K, Hara M, Isurugi K, Uchikawa T, Niijima T. Measurement of urinary steroid profile in patients with adrenal tumor as a screening method for carcinoma. Endocrinol Jpn. 1985 Feb;32(1):29-37. doi: 10.1507/endocrj1954.32.29.
- Background: PubMed 11939242Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002 Mar;21(2):271-92. doi: 10.1016/s0167-6296(01)00130-8.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michiel N Kerstens, MD, PhD study director
University Medical Center Groningen
E Buitenwerf, MD principal investigator
University Medical Center Groningen
P.H.L.T. Bisschop, MD, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Incidentaloma and Adrenocortical Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324647, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.