An exploratory study to determine the genetic polymorphisms or mutations associated with type 1 diabetes and interstitial lung disease induced by immune checkpoint inhibitor; nivolumab

An exploratory study to determine the genetic polymorphisms or mutations associated with type 1 diabetes and interstitial lung disease induced by immune checkpoint inhibitor; nivolumab - An exploratory study to determine the irAE-related genes induced by immune checkpoint inhibitor; nivolumab

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000030495

Enrollment

130

Registered

2017-12-21

Start date

2018-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

type 1 diabetes interstitial lung disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The cohort includes the patients treated with nivolumab who develops type 1 diabetes (n=15) and interstitial lung disease(n=50) as case group and the patients without immune-related adverse events (n=65) as control group. Whole genome data in healthy subjects were utilized from Tohoku Medical Megabank or NBDC as a collaboration.

Exclusion criteria

Exclusion criteria: The patient whom the researcher consider to be inappropriate for the study.

Design outcomes

Primary

Measure	Time frame
Allele frequency of causal variants or mutations associated with immune-related adverse events of nivolumab	—

Countries

Japan

Contacts

Public ContactNorio Abiru

Nagasaki University Hospital Department of Endocrinology and Metabolism

abirun@nagasaki-u.ac.jp095-819-7260

Outcome results