Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy

Endocrinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04079647
• Other study ID #: 201805155RIND
• Status: Recruiting
• Start date: July 3, 2018
• Est. completion date: July 1, 2025

Study information

• Verified date: August 2019
• Source: National Taiwan University Hospital
• Contact: Shyang-Rong Shih
• Phone: +886-972653337
• Email: srshih[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Endocrine System Diseases
• Endocrinopathy

Intervention

Drug:
• Immunotherapy
Patients receive immunotherapy for cancer treatment

Locations

Country	Name	City	State
Taiwan	Shyang-Rong Shih	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of endocrine profiles	Changes of serum fT4 TSH Glucose A1C ACTH cortisol LH FSH estradiol progesterone GH IGF1 prolactin	10 year
Secondary	Treatment response of the cancer after immunotherapy	The changes of size and extent of the tumors	10 years