Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04079647

Enrollment

200

Registered

2019-09-06

Start date

2018-07-03

Completion date

2025-07-01

Last updated

2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocrinopathy

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.

Interventions

DRUGImmunotherapy

Patients receive immunotherapy for cancer treatment

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Taiwan

Contacts

Primary ContactShyang-Rong Shih

srshih@ntu.edu.tw+886-972653337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026