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The goal of this study is to find out whether hypothyroidism caused by immune checkpoint inhibitors (ICIs) can recover after stopping the ICIs. The study also aims to identify factors that can help predict which patients will be able to stop taking thyroid hormone replacement.
The main questions the study will answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levothyroxine tapering arm | Experimental | Participants will undergo a gradual dose reduction of levothyroxine according to a standardized tapering protocol. The levothyroxine dose will be reduced every 3 months based on thyroid function test results. If thyroid function remains stable, the dose will be decreased by 0.025 mg (±0.0125 mg). If thyroid function remains stable at a low dose (≤0.025 mg), levothyroxine will be discontinued. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine tapering | Drug | Participants will undergo a gradual dose reduction of levothyroxine according to a standardized tapering protocol. The levothyroxine dose will be reduced every 3 months based on thyroid function test results. If thyroid function remains stable, the dose will be decreased by 0.025 mg (±0.0125 mg). If thyroid function remains stable at a low dose (≤0.025 mg), levothyroxine will be discontinued. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who maintain discontinuation of levothyroxine for at least 6 months | The number and proportion of participants who are able to remain off levothyroxine for at least 6 consecutive months without requiring re-initiation of treatment due to abnormal thyroid function (serum TSH level ≥10 μIU/mL). | Up to 6 months after levothyroxine discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who can discontinue levothyroxine | The number and proportion of participants who were able to discontinue levothyroxine after dose reduction during the study follow-up period, regardless of whether the discontinuation was sustained. This includes any participant who temporarily stopped levothyroxine for any duration, even if the medication was later resumed. | up to 3 years after study enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Joo Kim, Professor | Contact | +82-31-787-7855 | mjkim@snubh.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Seoul National University Bundang Hospital | Recruiting | Seongnam-si | South Korea |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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This is a prospective, single-group, open-label study designed to evaluate the potential for recovery from immune checkpoint inhibitor (ICI)-induced hypothyroidism after discontinuation of ICI therapy. All participants will receive a standardized protocol for stepwise reduction of levothyroxine dosage based on thyroid function tests. No comparator group is included.
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| Proportion of participants who maintain discontinuation of levothyroxine for at least 12 months | The number and proportion of participants who are able to remain off levothyroxine for at least 12 consecutive months without requiring re-initiation of treatment due to abnormal thyroid function (serum TSH level ≥10 μIU/mL). | Up to 12 months after levothyroxine discontinuation |
| Proportion of participants who maintain discontinuation of levothyroxine for at least 36 months | The number and proportion of participants who are able to remain off levothyroxine for at least 36 consecutive months without requiring re-initiation of treatment due to abnormal thyroid function (serum TSH level ≥10 μIU/mL). | Up to 36 months after levothyroxine discontinuation |