Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy

Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy and Metabolic Diseases -a Case Series of Taiwanese Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Endocrinopathy
• Intervention / Treatment: Drug: Immunotherapy

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Shyang-Rong Shih; Phone Number: +886-972653337; Email: srshih@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Shyang-Rong Shih
    • Contact: Shyang-Rong Shih, MD PHD; Phone Number: 61613 886-23123456; Email: srshih@ntu.edu.tw
    • Principal Investigator: Shyang-Rong Shih

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who receive immunotherapy in NTUH and develop endocrinopathy after therapy

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with endocrinopathy after immunotherapy	Drug: Immunotherapy; Patients receive immunotherapy for cancer treatment; Other Names: Immune blockade therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of endocrine profiles	Changes of serum fT4 TSH Glucose A1C ACTH cortisol LH FSH estradiol progesterone GH IGF1 prolactin	10 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response of the cancer after immunotherapy	The changes of size and extent of the tumors	10 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2018
• Primary Completion (ANTICIPATED): July 1, 2025
• Study Completion (ANTICIPATED): July 1, 2025

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (ACTUAL): September 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases
• Other Study ID Numbers: 201805155RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No