Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:40 AM
Study NCT ID:
NCT07421869
Status:
RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial
Sponsor:
Seoul National University Bundang Hospital
Organization:
Study Overview
Official Title:
SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
S-CORT
Brief Summary:
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:
* What percentage of patients recover normal thyroid function and can stop levothyroxine after stopping ICIs?
* What clinical or laboratory factors can predict successful withdrawal of levothyroxine?
Participants will:
* Be adult cancer patients who developed hypothyroidism during ICI treatment and are currently taking levothyroxine
* Have already stopped ICI therapy
* Gradually reduce their levothyroxine dose every 3 months if their thyroid function remains normal
* Stop levothyroxine if thyroid function remains normal at low doses (≤0.025 mg)
* Be monitored with thyroid function tests and clinical symptoms at each visit
The main questions the study will answer are:
* What percentage of patients recover normal thyroid function and can stop levothyroxine after stopping ICIs?
* What clinical or laboratory factors can predict successful withdrawal of levothyroxine?
Participants will:
* Be adult cancer patients who developed hypothyroidism during ICI treatment and are currently taking levothyroxine
* Have already stopped ICI therapy
* Gradually reduce their levothyroxine dose every 3 months if their thyroid function remains normal
* Stop levothyroxine if thyroid function remains normal at low doses (≤0.025 mg)
* Be monitored with thyroid function tests and clinical symptoms at each visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: