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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 107}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-03-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-01-31', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants who maintain discontinuation of levothyroxine for at least 6 months', 'timeFrame': 'Up to 6 months after levothyroxine discontinuation', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants who can discontinue levothyroxine', 'timeFrame': 'up to 3 years after study enrollment', 'description': '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.'}, {'measure': 'Proportion of participants who maintain discontinuation of levothyroxine for at least 12 months', 'timeFrame': 'Up to 12 months after levothyroxine discontinuation', 'description': '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).'}, {'measure': 'Proportion of participants who maintain discontinuation of levothyroxine for at least 36 months', 'timeFrame': 'Up to 36 months after levothyroxine discontinuation', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypothyroidism', 'Immune checkpoint inhibitors', 'Thyroid hormones', 'Levothyroxine'], 'conditions': ['Hypothyroidism']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions the study will answer are:\n\n* What percentage of patients recover normal thyroid function and can stop levothyroxine after stopping ICIs?\n* What clinical or laboratory factors can predict successful withdrawal of levothyroxine?\n\nParticipants will:\n\n* Be adult cancer patients who developed hypothyroidism during ICI treatment and are currently taking levothyroxine\n* Have already stopped ICI therapy\n* Gradually reduce their levothyroxine dose every 3 months if their thyroid function remains normal\n* Stop levothyroxine if thyroid function remains normal at low doses (≤0.025 mg)\n* Be monitored with thyroid function tests and clinical symptoms at each visit'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 19 years or older.\n* Patients with a history of treatment with immune checkpoint inhibitors (ICIs).\n* Developed hypothyroidism during ICI treatment and initiated levothyroxine after starting ICI therapy.\n* Discontinued ICI therapy prior to study enrollment.\n\nExclusion Criteria:\n\n* Use of levothyroxine or antithyroid medications within 3 months prior to initiating ICI therapy.\n* History of thyroid surgery, radioactive iodine therapy, or neck radiation therapy.\n* Current levothyroxine dose ≥0.1 mg at the time of enrollment.'}, 'identificationModule': {'nctId': 'NCT07421869', 'acronym': 'S-CORT', 'briefTitle': 'SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial', 'orgStudyIdInfo': {'id': 'IRB-B-2401-879-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levothyroxine tapering arm', 'description': '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.', 'interventionNames': ['Drug: Levothyroxine tapering']}], 'interventions': [{'name': 'Levothyroxine tapering', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Levothyroxine tapering arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Department of Internal Medicine, Seoul National University Bun', 'role': 'CONTACT', 'email': 'hjk@snubh.org', 'phone': '+82-787-7029'}], 'facility': 'Department of Internal Medicine, Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Min Joo Kim, Professor', 'role': 'CONTACT', 'email': 'mjkim@snubh.org', 'phone': '+82-31-787-7855'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Min Joo Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}