Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer
1 other identifier
interventional
20
1 country
2
Brief Summary
The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 22, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMarch 14, 2014
March 1, 2014
10 months
April 22, 2013
March 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TSH level at the end of study
The percentage of patients obtaining TSH level at least 30 imU/L at the end of study period. Blood tests will be obtained after 4 weeks. If TSH \> 30 the patient has completed the study. If TSH \< 30 patient will continue for 1 week and blood tests will be obtained after week 5. If TSH \> 30 the patient has completed the study. If TSH \< 30 patient will be monitored during 1 week and blood tests will be obtained after 6 weeks.
4-6 weeks
Secondary Outcomes (1)
change in Billewitz index during the study
4-6 weeks
Other Outcomes (1)
change in biochemical parameters during the study
4-6 weeks
Study Arms (1)
L-thyroxin
EXPERIMENTALthis is one arm study
Interventions
Low dose of L-thyroxin (50 microg/day) will be used during 4 weeks. If TSH is \< 30 after 4 weeks the study continues up to 6 weeks.
Eligibility Criteria
You may qualify if:
- Differentiated thyroid cancer
- treated by thyroidectomy and at least 1 ablation with 131-I \> 5 months ago
- TSH \< 4 imU/L
You may not qualify if:
- Pregnancy
- Known metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
East Tallinn Central Hospital
Tallinn, 10138, Estonia
Tartu University Hospital
Tartu, 50406, Estonia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vallo Volke, MD, PhD
University of Tartu
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
April 22, 2013
First Posted
April 25, 2013
Study Start
April 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 14, 2014
Record last verified: 2014-03