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Preoperative Corticosteroids in Autoimmune Thyroid Disease

StatusRecruiting
PhasePhase 4
Started2023-06-16
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 30, 2026 → Dec 30, 2026
See other at-risk trials from Indiana University

Amendment history

2026-08-03
Study Status, IPDSharing v7
Primary completion pushed: 2026-06-30 → 2026-12-30
Completion pushed: 2026-12-30 → 2027-06-30
2025-04-28
Study Status, Outcome Measures, Eligibility, Contacts/Locations v6
Primary completion date2025-12-31→2026-06-30
Completion date2026-06-30→2026-12-30
Secondary endpoints14 entries, revised
UltrasoundChange doppler quantification ofin blood flow / vascularity NumberSurgical complication of participantstransient withhypocalcemia Surgical thecomplication followingof surgicalpermanent complications:hypocalcemia CalciumSurgical complication of transient hypoparathyroidism Surgical complication of permanent hypoparathyroidism Surgical complication of recurrent laryngeal nerve palsy Change in SF-1220 at 6 weeks PTH TSH FT4 TT3Change in SF-20 at 6 months
Study sites3 entries, revised
IU Health North Hospital IU Health Methodist Hospital IU Health University Hospital
2025-01-22
Study Status, Contacts/Locations, IPDSharing v5
Completion date2025-12-31→2026-06-30
2023-12-07
Study Status, Eligibility v4
Start date2023-07-14→2023-06-16
Eligibility criteria-46 characters
[...] iagnosis of thyroid cancer Diabetic patients on medications A history of adverse reactions to corticosteroids. Patients on any immunosuppressive regimen (such as organ tra [...] his includes patients with recent history of steroid therapy. A, or a history of adverse reactions to corticosteroids. Patients who are receiving a concomitant medication that interacts negatively with corticosteroids.
2023-11-16
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-09-01→confirmed 2023-07-14
Study sites0→3
Show 2 earlier versions
2023-05-16
Study Status, Outcome Measures v2
Start date2022-10-01→2023-09-01
Secondary endpoints2 to 14 entries
Calcium SF-12 PTH TSH FT4 TT3 Tg TgAB TPO TSI TRAb ThyPRO
Primary endpoints13 to 1 entries
Calcium FT4 PTH SF-12 TPO TRAb TSH TSI TT3 Tg TgAB ThyPRO
2022-08-29
Study Status v1
Start date2022-07-01→2022-10-01
2022-06-23
Original filing
This study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.
Trial Details
NCT Number NCT05435547
Lead Sponsor Indiana University
Conditions Graves Disease, Hashimoto Disease
Enrollment 76 participants
Start Date 2023-06-16
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-05