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Recruiting NCT06794190

Characterization of Hepatopathy in Turner Syndrome: Analysis of Determinants

Observational Turner Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Turner Syndrome. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Characterization of Hepatopathy in Turner Syndrome: Analysis of Determinants in an Observational Study

Overview

The present study is therefore aimed at investigating the prevalence of hepatic alterations (laboratory and imaging) in adult patients with TS and generating hypothesissto the possible etiopathogenetic factors most involved, as well as evaluating the correlation between biochemical and structural abnormalities. Thus, the study could provide relevant etiopathogenetic and prognostic results on the development of hepatopathy in TS patients.

Detailed description

The study is an observational retrospective cohort type; patients with TS in longitudinal monitoring at the U.O.C. of Endocrinology and Diabetes Prevention and Care, DIMEC, of IRCCS Policlinico S. Orsola of Bologna will be enrolled. The diagnosis of TS was made for most patients by the Pediatrics unit of Policlinico S. Orsola; in rare cases it was performed in adulthood by our operating unit or at another center; in all cases, the diagnosis was made by karyotype analysis on peripheral blood.

The patients, as per clinical practice, underwent clinical evaluation with measurement of anthropometric parameters; an evaluation of the patients' medical history will be performed, paying attention to possible diagnosis of metabolic comorbidities and autoimmune diseases. Complete information regarding the history of menstrual cycles and replacement therapies used will also be collected. Finally, laboratory investigations are planned.

Primary outcome measures

  • Factors associated with hepatopathy [Time frame: Baseline]
Secondary outcome measures (2)
  • Comparison of liver morpho-functional parameters with results obtained by fibroscan. [Time frame: Baseline]
  • Comparison of liver morpho-functional parameters with results obtained by fibroscan. [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Diagnosis of Turner syndrome made by karyotype analysis on peripheral blood.
  • Age 18 years or older
  • Written informed consent obtained

Exclusion criteria

  • TS patients on therapy with drugs responsible for significant liver enzyme alterations (liver function alteration, LFA).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna

Identifiers

NCT: NCT06794190 · LIVER_TS-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗