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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-01-30/R3 | Other Identifier | Klinikum Luedenscheid |
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In this study, patients are prospectively followed after radioiodine treatment to assess the relationship between thyroid status and their quality of life after thyroid ablative treatment.
A third treatment arm after surgery has been stopped, as deemed currently not feasible to achieve its target.
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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery (withdrawn, not continuing recruiting) | thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy |
| |
| radioiodine | thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment |
| |
| control | thyroid patients followed without surgery or radioiodine treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine Sodium | Drug | thyroid hormone replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| ThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life) | quality of life measured by a thyroid specific validated questionnaire | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters) | efficiency of converting T4 into T3 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of TSH | TSH | 6 months |
| Serum Concentrations of FT3 and FT4 | Thyroid hormones FT3, FT4 | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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thyroid patients in a routine ambulatory setting specialising in Nuclear Medicine
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Larisch, Professor | Director of Department | Principal Investigator |
| Rudolf Hoermann, Professor | Klinikum Lüdenscheid | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine Klinikum Luedenscheid | Lüdenscheid | North Rhine-Westphalia | 58515 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29396968 | Background | Larisch R, Midgley JEM, Dietrich JW, Hoermann R. Symptomatic Relief is Related to Serum Free Triiodothyronine Concentrations during Follow-up in Levothyroxine-Treated Patients with Differentiated Thyroid Cancer. Exp Clin Endocrinol Diabetes. 2018 Sep;126(9):546-552. doi: 10.1055/s-0043-125064. Epub 2018 Feb 2. | |
| 29375474 | Background |
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Data are principally shared depending on compliance with relevant regulations and authorisation
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgery (Withdrawn, Not Continuing Recruiting) | thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy Levothyroxine Sodium: thyroid hormone replacement |
| FG001 | Radioiodine | thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment Levothyroxine Sodium: thyroid hormone replacement |
| FG002 | Control | thyroid patients followed without surgery or radioiodine treatment Levothyroxine Sodium: thyroid hormone replacement |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | euthyroid patients presenting at fixed intervals for surveillance of non-toxic nodular goitre |
| BG001 | Radioiodine | Untreated patients with subclinical hyperthyroidism referred for radioiodine treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life) | quality of life measured by a thyroid specific validated questionnaire | Posted | Mean | Standard Deviation | score | 6 months |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Control group | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Rolf Larisch, Director | Klinikum Lüdenscheid | +49 2351 46 | 3311 | rolf.larisch@klinikum-luedenscheid.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2019 | Aug 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| Thyroid Volume Measured by Ultrasound (ml) | thyroid capacity | 6 months |
| Hoermann R, Midgley JEM, Larisch R, Dietrich JW. Recent Advances in Thyroid Hormone Regulation: Toward a New Paradigm for Optimal Diagnosis and Treatment. Front Endocrinol (Lausanne). 2017 Dec 22;8:364. doi: 10.3389/fendo.2017.00364. eCollection 2017. |
| 30022470 | Background | Hoermann R, Midgley JEM, Larisch R, Dietrich JW. The role of functional thyroid capacity in pituitary thyroid feedback regulation. Eur J Clin Invest. 2018 Oct;48(10):e13003. doi: 10.1111/eci.13003. Epub 2018 Aug 1. |
| 26635726 | Background | Hoermann R, Midgley JE, Larisch R, Dietrich JW. Homeostatic Control of the Thyroid-Pituitary Axis: Perspectives for Diagnosis and Treatment. Front Endocrinol (Lausanne). 2015 Nov 20;6:177. doi: 10.3389/fendo.2015.00177. eCollection 2015. |
| 29155897 | Background | Hoermann R, Midgley JEM, Larisch R, Dietrich JWC. Advances in applied homeostatic modelling of the relationship between thyrotropin and free thyroxine. PLoS One. 2017 Nov 20;12(11):e0187232. doi: 10.1371/journal.pone.0187232. eCollection 2017. |
| 26335522 | Background | Midgley JE, Larisch R, Dietrich JW, Hoermann R. Variation in the biochemical response to l-thyroxine therapy and relationship with peripheral thyroid hormone conversion efficiency. Endocr Connect. 2015 Dec;4(4):196-205. doi: 10.1530/ec-150056. |
| 23184912 | Background | Hoermann R, Midgley JE, Larisch R, Dietrich JW. Is pituitary TSH an adequate measure of thyroid hormone-controlled homoeostasis during thyroxine treatment? Eur J Endocrinol. 2013 Jan 17;168(2):271-80. doi: 10.1530/EJE-12-0819. Print 2013 Feb. |
| 27257805 | Background | Winther KH, Cramon P, Watt T, Bjorner JB, Ekholm O, Feldt-Rasmussen U, Groenvold M, Rasmussen AK, Hegedus L, Bonnema SJ. Disease-Specific as Well as Generic Quality of Life Is Widely Impacted in Autoimmune Hypothyroidism and Improves during the First Six Months of Levothyroxine Therapy. PLoS One. 2016 Jun 3;11(6):e0156925. doi: 10.1371/journal.pone.0156925. eCollection 2016. |
| 27375554 | Background | Dietrich JW, Landgrafe-Mende G, Wiora E, Chatzitomaris A, Klein HH, Midgley JE, Hoermann R. Calculated Parameters of Thyroid Homeostasis: Emerging Tools for Differential Diagnosis and Clinical Research. Front Endocrinol (Lausanne). 2016 Jun 9;7:57. doi: 10.3389/fendo.2016.00057. eCollection 2016. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| FT3 | Mean | Standard Deviation | pmol/L |
|
| FT4 | Mean | Standard Deviation | pmol/L |
|
| TSH | Median | Inter-Quartile Range | mIU/L |
|
| Thyroid volume | Mean | Standard Deviation | ml |
|
|
|
|
| Secondary | Rate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters) | efficiency of converting T4 into T3 | Posted | Mean | Standard Deviation | nmol/s | 6 months |
|
|
|
|
| Other Pre-specified | Serum Concentration of TSH | TSH | Posted | Mean | Standard Deviation | mIU/L | 6 months |
|
|
|
|
| Other Pre-specified | Serum Concentrations of FT3 and FT4 | Thyroid hormones FT3, FT4 | Posted | Mean | Standard Deviation | pmol/L | 6 months |
|
|
|
|
| Other Pre-specified | Thyroid Volume Measured by Ultrasound (ml) | thyroid capacity | Posted | Mean | Standard Deviation | ml | 6 months |
|
|
|
|
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Radioiodine | Treatment group | 1 | 51 | 0 | 51 | 0 | 51 |
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| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| 0.12 |
| Mean Difference (Final Values) |
| -0.83 |
| 2-Sided |
| 95 |
| -1.81 |
| 0.15 |
| Superiority |