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Quality of Life After Surgery and Radioiodine Treatment (DSR)

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ClinicalTrials.gov Identifier: NCT03880578
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Klinikum Lüdenscheid

Brief Summary:
In this study, patients are prospectively followed after surgery or radioiodine treatment to assess the relationship between thyroid status and their quality of life after thyroid ablative treatment.

Condition or disease Intervention/treatment
Thyroid; Deficiency Quality of Life Drug: Levothyroxine Sodium

Detailed Description:

Patients are frequently dissatisfied with LT4 replacement treatment. The reasons for persisting patient complaints are poorly understood. Conversion efficiency and impaired T3/T4 ratios in athyreotic patients may play a major role. We hypothesised that the extent of ablation either by surgery or radioiodine treatment may result in biochemical disequilibria between FT3, FT4 and TSH and those may be, in turn, associated with persisting symptomatology.

The study follows patients after surgery or radioiodine therapy as well as a control group over half a year, assessing thyroid status, set points, conversion rates, thyroid volume, LT4 administration and dosing, demographic characteristics and quality of life measures. The treatment mode is not part of the study, and determined by criteria and procedures of best standard care. For that reason, a randomised or blinded design is not possible.

Changes and interrelationships between thyroid parameters and QoL measures are analysed within-subjects and between treatment groups.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Surgery and Radioiodine Treatment on Thyroid Function and Quality of Life of Patients
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Group/Cohort Intervention/treatment
surgery
thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy
Drug: Levothyroxine Sodium
thyroid hormone replacement
Other Name: LT4

radioiodine
thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment
Drug: Levothyroxine Sodium
thyroid hormone replacement
Other Name: LT4

control
thyroid patients followed without surgery or radioiodine treatment
Drug: Levothyroxine Sodium
thyroid hormone replacement
Other Name: LT4




Primary Outcome Measures :
  1. ThyPRO scale scores (0-100, higher scores indicating worse quality of life) [ Time Frame: 6 months ]
    quality of life measured by a thyroid specific validated questionnaire


Secondary Outcome Measures :
  1. rate of global deiodinase activity (SPINA-GD, see reference calculated parameters) [ Time Frame: 6 months ]
    efficiency of converting T4 into T3


Other Outcome Measures:
  1. serum concentrations of TSH, FT4, FT3 [ Time Frame: 6 months ]
    biochemical thyroid function tests

  2. thyroid volume measured by ultrasound (ml) [ Time Frame: 6 months ]
    thyroid capacity



Information from the National Library of Medicine

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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
thyroid patients in a routine ambulatory setting specialising in Nuclear Medicine
Criteria

Inclusion Criteria:

  • Clinical diagnosis of a thyroid disease requiring surgery or radioiodine treatment
  • Clinical diagnosis of a thyroid disease requiring follow-up but no ablative treatment (controls)

Exclusion Criteria:

  • paediatric patients
  • interfering comorbidity
  • non-thyroidal illness
  • pregnancy
  • psychiatric disease
  • severe psychological disorder
  • lack of 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): NCT03880578


Contacts
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Contact: Rolf Larisch, Professor ‭+49 2351 463311‬ rolf.larisch@klinikum-luedenscheid.de
Contact: Rudolf Hoermann, Professor rudolf.hoermann@gmail.com

Locations
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Germany
Department of Nuclear Medicine Klinikum Luedenscheid Recruiting
Luedenscheid, NRW, Germany, 58515
Contact: Rolf Larisch, Prof    +492351463311    rolf.larisch@klinikum-luedenscheid.de   
Contact: Hagedorn-Krüger, MD    +492351463311      
Principal Investigator: Rolf Larisch, Prof         
Sub-Investigator: Hagedorn-Krüger, MD         
Sponsors and Collaborators
Klinikum Lüdenscheid
Investigators
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Principal Investigator: Rolf Larisch, Professor Director of Department
Study Chair: Rudolf Hoermann, Professor Klinikum Lüdenscheid

Publications:

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Responsible Party: Klinikum Lüdenscheid
ClinicalTrials.gov Identifier: NCT03880578     History of Changes
Other Study ID Numbers: 2019-01-30/R3
2019-01-30/R3 ( Other Identifier: Klinikum Luedenscheid )
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data are principally shared depending on compliance with relevant regulations and authorisation

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Klinikum Lüdenscheid:
LT4 treatment
QoL

Additional relevant MeSH terms:
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Thyroid Diseases
Hypothyroidism
Endocrine System Diseases