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RECRUITING
NCT06307990

Understanding, Diagnosis and Monitoring of Thyroid Hormone Action Defects

Sponsor: Istituto Auxologico Italiano

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn about the neurological and cardiological phenotype of patients with resistance to thyroid hormone (RTH) syndromes beta and alpha (RTHß and RTHa) due to dominant negative variants in the genes encoding the thyroid hormone receptors alpha (THRA) and beta (THRB). The main question\[s\] it aims to answer are: * Define frequency and improve early diagnosis for RTH syndromes * Developing tools to accelerate diagnosis of RTH syndromes * Development and validation of monitoring tools Participants, recruited at neonatal screening or from cohorts of patients with unexplained specific neuro-cognitive or cardiovascular phenotypes will be submitted to biochemical and genetic investigations. In addition pluripotent stem cells will be generated from peripheral blood cells of RTHs patients and studied in vitro to understand the molecular mechanisms underlying neurological and cardiovascular consequences. In vitro and clinical data, will be correlated to identify biomarkers for monitoring treatment.

Official title: Advancing Understanding, Diagnosis and Monitoring of Thyroid Hormone Action Defects (ADAM-THAD)

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2023-01-01

Completion Date

2026-01-31

Last Updated

2025-09-02

Healthy Volunteers

Yes

Interventions

GENETIC

NGS sequencing

analysis of candidate genes for RTHs syndromes, transporters defects or gene involved in thyroid hormone metabolism. Whole exome sequencing (WES) in a minority of cases

DIAGNOSTIC_TEST

serological tests

assessment of T4, T3 and other TH metabolites (LC-MS) in serum and dried blood spots

Locations (2)

Istituto Auxologico Italiano IRCCS

Milan, Italy

Department of Endocrine & Metabolic Diseases, San Luca Hospital

Milan, Italy