Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Turner And Klinefelter Treatment Target Study (TAKTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04803474
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
dr. Laura C. G. de Graaff-Herder, Erasmus Medical Center

Brief 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.


Condition or disease Intervention/treatment
Klinefelter Syndrome Turner Syndrome Diagnostic Test: Measurement of blood values, questionnaire scores and measurements of hormone levels in hair

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 370 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Turner And Klinefelter Treatment Target Study. Improving Endocrine Treatment by Linking Biochemical Parameters to Morbidity and Quality of Life in Patients With Turner and Klinefelter Syndrome
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 1, 2021


Group/Cohort Intervention/treatment
Klinefelter
Patients with Klinefelter syndrome
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

Turner
Patient with Turner syndrome
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




Primary Outcome Measures :
  1. The relationship between thyroid hormone status* and QoL as measured by the EQ-5D-5L in patients with TS. [ Time Frame: At study entry (cross-sectional study). There is just one visit per patient. The total study has an approximately duration of 3-4 years. ]

    thyroid hormone status is a variable that consists of the following 6 categories:

    • Overt hyperthyroidism (FT4>25pmol/L and TSH<0,4mU/L)
    • Overt hypothyroidism (FT4 <11 pmol/L and TSH >4,3 mU/L)
    • Subclinical hypothyroidism with TSH <10mU/L (FT4 11-25 pmol/L and TSH 4,3-10mU/L)
    • Subclinical hypothyroidism with TSH >10mU/L (FT4 11-25 pmol/L and TSH > 10mU/L)
    • Subclinical hyperthyroidism (FT4 11-25 pmol/L and TSH <0,4 mU/L)
    • Euthyroidism (FT4 11-25 pmol/L and TSH 0,4- 4,3 mU/L)

    The range of the EQ-5D-5L is from 0 to 100. A higher score means a better outcome.


  2. The relationship between testosterone concentrations in hair and QoL as measured by the EQ-5D-5L in patients with KS. [ Time Frame: At study entry (cross-sectional study). There is just one visit per patient. The total study has an approximately duration of 3-4 years. ]
    The range of the EQ-5D-5L is from 0 to 100. A higher score means a better outcome.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with KS and TS of 18 years or older that visit the outpatients clinic of the EMC, AMC or the VUmc will be included. Approximately 120 KS and 250 TS patients are intended to be included.
Criteria

Inclusion Criteria:

  • Klinefelter or Turner syndrome as confirmed by genetic testing
  • Sufficient knowledge of the Dutch language to complete the questionnaires
  • At least 18 years old

Exclusion Criteria:

  • KS: Patients not under treatment in the EMC, AMC or VUmc or no planned visits during the study period
  • TS: No laboratory values or no questionnaires available in patient records
  • Severe psychiatric or neurologic disorders or other reasons for inability to complete the questionnaires as assessed by the treating physician.
  • Failure to obtain informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803474


Contacts
Layout table for location contacts
Contact: Laura de Graaff, MD, PhD +31618843010 l.degraaff@erasmusmc.nl

Locations
Layout table for location information
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 GD
Contact: Laura CG de Graaff, MD, PhD    +31618843010    l.degraaff@erasmusmc.nl   
Sub-Investigator: Sabine E Hannema         
Sponsors and Collaborators
dr. Laura C. G. de Graaff-Herder
Investigators
Layout table for investigator information
Principal Investigator: Laura de Graaff, MD, PhD Department of Internal Medicine - Endocrinology, Erasmus MC, Rotterdam, the Netherlands
Layout table for additonal information
Responsible Party: dr. Laura C. G. de Graaff-Herder, Principal investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04803474    
Other Study ID Numbers: NL65814.078.18
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data available upon reasonable request

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Turner Syndrome
Gonadal Dysgenesis
Klinefelter Syndrome
Syndrome
Disease
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs