Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy

NCT ID: NCT04079647

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-03

Study Completion Date

2025-07-01

Brief Summary

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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

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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.

Conditions

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Endocrinopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient with endocrinopathy after immunotherapy

Patient with endocrinopathy after immunotherapy

Immunotherapy

Intervention Type DRUG

Patients receive immunotherapy for cancer treatment

Interventions

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Immunotherapy

Patients receive immunotherapy for cancer treatment

Intervention Type DRUG

Other Intervention Names

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Immune blockade therapy

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shyang-Rong Shih, MD, PhD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

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Shyang-Rong Shih

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shyang-Rong Shih

Role: CONTACT

+886-972653337

Facility Contacts

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Shyang-Rong Shih, MD PHD

Role: primary

886-23123456 ext. 61613

Other Identifiers

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201805155RIND

Identifier Type: -

Identifier Source: org_study_id

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