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Turner And Klinefelter Treatment Target Study

NCT04803474 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 370

Last updated 2023-09-06

No results posted yet for this study

Summary

Rationale: Health related Quality of life (HRQoL) is impaired in patients with Turner and Klinefelter syndrome (TS and KS). It is unknown what the optimal endocrine treatment target values are that maximize HRQoL in patients with these syndromes. Therefore the relation between HRQoL and biochemical parameters will be studied in large cohorts of patients with TS and KS. This information will give essential insight that will help to improve endocrine treatment and HRQoL in these patients.

Research objectives: To explore the relationship between biochemical parameters and HRQoL in patients with TS and KS.

Hypothesis: Biochemical parameters are related to HRQoL in patients with TS and KS.

Study design: Cross-sectional, observational, multicentre study Study population: Patients with KS or TS, 18 years or older Methods and procedures: To measure fatigue the Checklist Individual Strength (CIS-20) will be used, for QoL the 5-level EQ-5D (EQ-5D-L5) will be used and for stress the Perceived Stress Scale (PSS) and hair cortisol levels. For patients with KS the anxiety scale from the Liebowitz social anxiety scale (LSAS) will be used to measure social anxiety. To measure the long-term exposure to testosterone in KS patients, testosterone concentrations in hair will be measured. For patients with KS, all questions from the questionnaires will be discussed orally during a visit to the outpatients clinic. One extra tube of blood and a strand of hair will be collected during routine blood withdrawal. All other variables are already part of the standard patient care and are available in patient records. For patients with TS all information including the questionnaires and laboratory values is already available and will be collected from clinical records.

Main study parameters/endpoints: The relationship between different hormonal parameters and HRQoL as measured by questionnaires. The main hormonal parameter that will be investigated in KS is testosterone in hair. For patients with Turner syndrome, free thyroxine (FT4), thyroid stimulating hormone (TSH) and liver enzymes, which have already been collected, will be investigated. The relationships between the EQ-5D-L5 score and testosterone in hair (in patients with KS) and thyroid hormone status (in patients with TS) are the primary outcomes.

Conditions

  • Klinefelter Syndrome
  • Turner Syndrome

Interventions

DIAGNOSTIC_TEST

Measurement of blood values, questionnaire scores and measurements of hormone levels in hair

Measurement of blood values, questionnaire scores and measurements of hormone levels in hair

Sponsors & Collaborators

  • dr. Laura C. G. de Graaff-Herder

    lead OTHER

Principal Investigators

  • Laura de Graaff, MD, PhD · Department of Internal Medicine - Endocrinology, Erasmus MC, Rotterdam, the Netherlands

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2024-07-01
Completion
2024-12-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803474 on ClinicalTrials.gov