NCT04079647

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 6, 2019

Status Verified

August 1, 2019

Enrollment Period

7 years

First QC Date

September 3, 2019

Last Update Submit

September 3, 2019

Conditions

Endocrinopathy

Outcome Measures

Primary Outcomes (1)

  • Changes of endocrine profiles

    Changes of serum fT4 TSH Glucose A1C ACTH cortisol LH FSH estradiol progesterone GH IGF1 prolactin

    10 year

Secondary Outcomes (1)

  • Treatment response of the cancer after immunotherapy

    10 years

Study Arms (1)

Patient with endocrinopathy after immunotherapy

Patient with endocrinopathy after immunotherapy

Drug: Immunotherapy

Interventions

ImmunotherapyDRUG

Patients receive immunotherapy for cancer treatment

Also known as: Immune blockade therapy
Patient with endocrinopathy after immunotherapy

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who receive immunotherapy in NTUH and develop endocrinopathy after therapy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shyang-Rong Shih

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Endocrine System Diseases

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Shyang-Rong Shih, MD, PhD

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Shyang-Rong Shih

CONTACT

+886-972653337srshih@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 6, 2019

Study Start

July 3, 2018

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

September 6, 2019

Record last verified: 2019-08

Locations

TW(1)