Trial Outcomes & Findings for Quality of Life After Interventional Thyroid Treatment (NCT NCT03880578)
NCT ID: NCT03880578
Last Updated: 2024-10-29
Results Overview
quality of life measured by a thyroid specific validated questionnaire
Recruitment status
COMPLETED
Target enrollment
101 participants
Primary outcome timeframe
6 months
Results posted on
2024-10-29
Participant Flow
Participant milestones
| Measure |
Surgery (Withdrawn, Not Continuing Recruiting)
thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy
Levothyroxine Sodium: thyroid hormone replacement
|
Radioiodine
thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment
Levothyroxine Sodium: thyroid hormone replacement
|
Control
thyroid patients followed without surgery or radioiodine treatment
Levothyroxine Sodium: thyroid hormone replacement
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
51
|
50
|
|
Overall Study
12 Months
|
0
|
14
|
19
|
|
Overall Study
COMPLETED
|
0
|
47
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
1
|
Reasons for withdrawal
| Measure |
Surgery (Withdrawn, Not Continuing Recruiting)
thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy
Levothyroxine Sodium: thyroid hormone replacement
|
Radioiodine
thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment
Levothyroxine Sodium: thyroid hormone replacement
|
Control
thyroid patients followed without surgery or radioiodine treatment
Levothyroxine Sodium: thyroid hormone replacement
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Quality of Life After Interventional Thyroid Treatment
Baseline characteristics by cohort
| Measure |
Control
n=50 Participants
euthyroid patients presenting at fixed intervals for surveillance of non-toxic nodular goitre
|
Radioiodine
n=51 Participants
Untreated patients with subclinical hyperthyroidism referred for radioiodine treatment
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
50 participants
n=5 Participants
|
51 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
FT3
|
5.32 pmol/L
STANDARD_DEVIATION 0.70 • n=5 Participants
|
5.45 pmol/L
STANDARD_DEVIATION 0.71 • n=7 Participants
|
5.39 pmol/L
STANDARD_DEVIATION 0.70 • n=5 Participants
|
|
FT4
|
15.4 pmol/L
STANDARD_DEVIATION 2.02 • n=5 Participants
|
15.3 pmol/L
STANDARD_DEVIATION 2.29 • n=7 Participants
|
15.3 pmol/L
STANDARD_DEVIATION 2.15 • n=5 Participants
|
|
TSH
|
1.25 mIU/L
n=5 Participants
|
0.39 mIU/L
n=7 Participants
|
0.75 mIU/L
n=5 Participants
|
|
Thyroid volume
|
19.8 ml
STANDARD_DEVIATION 10.3 • n=5 Participants
|
29.7 ml
STANDARD_DEVIATION 14.2 • n=7 Participants
|
24.7 ml
STANDARD_DEVIATION 13.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsquality of life measured by a thyroid specific validated questionnaire
Outcome measures
| Measure |
Control
n=50 Participants
Composite ThyPRO score
|
Radioiodine
n=51 Participants
Composite ThyPRo score
|
|---|---|---|
|
ThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life)
|
18.3 score
Standard Deviation 10.8
|
19.9 score
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: 6 monthsefficiency of converting T4 into T3
Outcome measures
| Measure |
Control
n=50 Participants
Composite ThyPRO score
|
Radioiodine
n=51 Participants
Composite ThyPRo score
|
|---|---|---|
|
Rate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters)
|
32.9 nmol/s
Standard Deviation 5.03
|
32.2 nmol/s
Standard Deviation 5.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsTSH
Outcome measures
| Measure |
Control
n=50 Participants
Composite ThyPRO score
|
Radioiodine
n=51 Participants
Composite ThyPRo score
|
|---|---|---|
|
Serum Concentration of TSH
|
1.39 mIU/L
Standard Deviation 0.63
|
2.34 mIU/L
Standard Deviation 2.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsThyroid hormones FT3, FT4
Outcome measures
| Measure |
Control
n=50 Participants
Composite ThyPRO score
|
Radioiodine
n=51 Participants
Composite ThyPRo score
|
|---|---|---|
|
Serum Concentrations of FT3 and FT4
FT3
|
5.33 pmol/L
Standard Deviation 0.60
|
4.84 pmol/L
Standard Deviation 0.65
|
|
Serum Concentrations of FT3 and FT4
FT4
|
15.2 pmol/L
Standard Deviation 2.13
|
14.2 pmol/L
Standard Deviation 2.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsthyroid capacity
Outcome measures
| Measure |
Control
n=50 Participants
Composite ThyPRO score
|
Radioiodine
n=51 Participants
Composite ThyPRo score
|
|---|---|---|
|
Thyroid Volume Measured by Ultrasound (ml)
|
20.5 ml
Standard Deviation 12.8
|
18.8 ml
Standard Deviation 10.3
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Radioiodine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place