Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy

Recruiting

• Conditions: Endocrinopathy
• Interventions: Drug: Immunotherapy

• Registration Number: NCT04079647
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

To review cases from NTUH who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response.

Detailed Description

Immune checkpoint blockade-based immunotherapy is a new modality of cancer treatment with a unique mechanism that has gained increased numbers of indication and is now used in several cancer types. However, immune-related adverse events (irAEs) emerge as a new entity of diseases involving one or multiple organ systems. irAEs could result in interruption of immunotherapy, morbidities of patients or even death. Among various manifestations of irAEs, endocrinopathy and metabolic diseases are rare but important, and require prompt diagnosis and treatment to avoid life-threatening conditions.

Thus, we intend to review cases from NTUH who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response. We will also review literatures to evaluate the difference and similarity from previous diagnostic and treatment experience.

Study Timeline

• Study Start: 2018-07-03
• Status Verified: 2019-08
• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-03
• Last Update Submitted: 2019-09-03
• Study First Posted: 2019-09-06
• Last Update Posted: 2019-09-06
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients who receive immunotherapy in NTUH and develop endocrinopathy after therapy

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Exclusion Criteria

• Patients less than 20 years old. Patients who are pregnant

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with endocrinopathy after immunotherapy	Immunotherapy	Patient with endocrinopathy after immunotherapy

Primary Outcome Measures

Name	Time	Method
Changes of endocrine profiles	10 year	Changes of serum fT4 TSH Glucose A1C ACTH cortisol LH FSH estradiol progesterone GH IGF1 prolactin

Secondary Outcome Measures

Name	Time	Method
Treatment response of the cancer after immunotherapy	10 years	The changes of size and extent of the tumors

Trial Locations

Locations (1)

Shyang-Rong Shih; 🇨🇳 Taipei, Taiwan