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NCT06980753

Continuous Steroid Monitoring in Interstitial Fluid With Wearable and Nanoparticle-enhanced Biosensors for Improved Management of Adrenal Disorders

Not yet recruiting NA Last updated 20 May 2025
What this trial tests

NA trial testing Participants will use the biossensor for 48 h in Cushing Syndrome in 246 participants. Not yet recruiting.

Timeline
1 June 2025
Primary endpoint
1 November 2025
1 December 2025

Quick facts

Lead sponsorUniversity of Sao Paulo General Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment246
Start date1 June 2025
Primary completion1 November 2025
Estimated completion1 December 2025
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

University of Sao Paulo General Hospital

Who can join

18 and older, any sex, with Cushing Syndrome or Primary Aldosteronism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this project is to provide novel technology that will pave the way from the present single-point (analogue) endocrinology towards continuous cortisol and aldosterone monitoring with full time resolution. Current endocrine practice relies on occasional and often random determination of hormone level or functional tests that require a clinical setting. These measurements include sample extraction and analysis in a clinical laboratory rendering such tests laborious and expensive. Most importantly, through the individual variations of hormone oscillation and spatiotemporal distribution of hormones, infrequent hormone measurements have limited diagnostic and prognostic value as the dynamic changes are not captured and relevant intra-individual variability occurs. A requirement for this vision are sensing solutions capable to track hormone dynamics over prolonged periods at high patient comfort (e.g., at home), as targeted by this research proposal. This project has the overarching goals of (1) establishing dynamic interstitial aldosterone and cortisol monitoring as reliable diagnostic tool for cortisol and aldosterone excess or deficiency, and (2) develop a wearable molecular sensing device to detect them accurately.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Designing the Future of Biosensing: Advances in Aptamer Discovery, Computational Modeling, and Diagnostic Applications.
    Jesky RG, Lo LHY, Siu RHP, Tanner JA. · · 2025 · PMID 41149291 · DOI 10.3390/bios15100637

Verify or expand the search:

Other recruiting trials for Cushing Syndrome

Currently open trials in the same condition.

Other University of Sao Paulo General Hospital trials

Trials by the same sponsor.

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Data sources for this page

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