NCT03880578

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 29, 2024

Completed
Last Updated

October 29, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

March 14, 2019

Results QC Date

January 9, 2024

Last Update Submit

October 26, 2024

Conditions

Thyroid; DeficiencyQuality of Life

Keywords

LT4 treatmentQoL

Outcome Measures

Primary Outcomes (1)

  • ThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life)

    quality of life measured by a thyroid specific validated questionnaire

    6 months

Secondary Outcomes (1)

  • Rate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters)

    6 months

Other Outcomes (3)

  • Serum Concentration of TSH

    6 months

  • Serum Concentrations of FT3 and FT4

    6 months

  • Thyroid Volume Measured by Ultrasound (ml)

    6 months

Study Arms (3)

surgery (withdrawn, not continuing recruiting)

thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy

Drug: Levothyroxine Sodium

radioiodine

thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment

Drug: Levothyroxine Sodium

control

thyroid patients followed without surgery or radioiodine treatment

Drug: Levothyroxine Sodium

Interventions

Levothyroxine SodiumDRUG

thyroid hormone replacement

Also known as: LT4
controlradioiodinesurgery (withdrawn, not continuing recruiting)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

thyroid patients in a routine ambulatory setting specialising in Nuclear Medicine

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine Klinikum Luedenscheid

Lüdenscheid, North Rhine-Westphalia, 58515, Germany

Location

Related Publications (9)

  • 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.

    PMID: 29396968BACKGROUND

  • 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.

    PMID: 29375474BACKGROUND

  • 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.

    PMID: 30022470BACKGROUND

  • 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.

    PMID: 26635726BACKGROUND

  • 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.

    PMID: 29155897BACKGROUND

  • 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.

    PMID: 26335522BACKGROUND

  • 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.

    PMID: 23184912BACKGROUND

  • 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.

    PMID: 27257805BACKGROUND

  • 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.

    PMID: 27375554BACKGROUND

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Professor Rolf Larisch, Director
Organization
Klinikum Lüdenscheid
rolf.larisch@klinikum-luedenscheid.de
‭+49 2351 46

Study Officials

  • Rolf Larisch, Professor

    Director of Department

    PRINCIPAL INVESTIGATOR

  • Rudolf Hoermann, Professor

    Klinikum Lüdenscheid

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 19, 2019

Study Start

April 1, 2019

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

October 29, 2024

Results First Posted

October 29, 2024

Record last verified: 2024-01

Locations

DE(1)