Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy | NCT04079647

Studies
Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy

NCT04079647

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Sep 6, 2019Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Endocrinopathy

Interventions

Immunotherapy

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2018Actual

Primary Completion Date

Jul 1, 2025Estimated

Completion Date

Jul 1, 2025Estimated

First Submitted Date

Sep 3, 2019

First Submission Date that Met QC Criteria

Sep 3, 2019

First Posted Date

Sep 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2019

Last Update Posted Date

Sep 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with endocrinopathy after immunotherapy		Patient with endocrinopathy after immunotherapy	Drug: Immunotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunotherapy	Drug	Patients receive immunotherapy for cancer treatment	Patient with endocrinopathy after immunotherapy

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who receive immunotherapy in NTUH and develop endocrinopathy after therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shyang-Rong Shih	Contact	+886-972653337		srshih@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Shyang-Rong Shih, MD, PhD	National Taiwan University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shyang-Rong Shih	Recruiting	Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D004700	Endocrine System Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007167	Immunotherapy

Ancestor Terms

ID	Term
D056747	Immunomodulation
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided