UMIN-CTR Clinical Trial

Basic information
Public title	HLA analysis in ACTH deficiency due to immune-related adverse events of PD1 antibody
Acronym	HLA analysis in ACTH deficiency due to irAE of PD1 antibody
Scientific Title	HLA analysis in ACTH deficiency due to immune-related adverse events of PD1 antibody
Scientific Title:Acronym	HLA analysis in ACTH deficiency due to irAE of PD1 antibody
Region	Japan

Condition
Condition	ACTH deficiency
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Recently, immune-checkpoint inhibitor (ICI) has been used for treatment of malignant tumors, and PD1 antibody, a representative ICI, is prescribed for non small cell lung cancer or urothelial cancer. ICI is effective even in the advanced cancer, however, it's known immune-related adverse events (irAE) including ACTH deficiency could happen. ACTH (adrenocorticotropic hormone) is secreted in anterior pituitary, and ACTH deficiency could cause adrenal failure (anorexia, body weight loss, hypotension, coma, shock, etc). Generally, the frequency of ACTH deficiency due to PD1-Ab is 1%. HLA (human leukocyte antigen) is known as essential factors to distinguish self and not-self, and it's possible HLA haplotype is associated with PD1-Ab induced ACTH deficiency. In this study, we are going to investigate susceptible HLA genotype in patients with PD1-Ab induced ACTH deficiency, and we could clarify the pathological mechanism for preventing ACTH deficiency in the future.
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysis of specific HLA genotypes in PD1-Ab induced ACTH deficiency patients
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	ACTH deficiency patients due to PD1 antibody therapy for malignant tumor in Kochi Medical School hospital.
Key exclusion criteria	None
Target sample size	8

Research contact person
Name of lead principal investigator	1st name MITSURU Middle name Last name NISHIYAMA
Organization	Kochi Medical School, Kochi University
Division name	Department of Endocrinology, Metabolism & Nephrology
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku city, Kochi 783-8505, Japan
TEL	088-880-2343
Email	nisiyamm@kochi-u.ac.jp

Public contact
Name of contact person	1st name MITSURU Middle name Last name NISHIYAMA
Organization	Kochi Medical School, Kochi University
Division name	Department of Endocrinology, Metabolism & Nephrology
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku city, Kochi 783-8505, Japan
TEL	088-880-2343
Homepage URL
Email	nisiyamm@kochi-u.ac.jp

Sponsor
Institute	Kochi University
Institute
Department

Funding Source
Organization	Others
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kochi Medical School, Center for Medical Sustainability and Innovation
Address	Kohasu, Oko-cho, Nankoku city, Kochi 783-8505, Japan
Tel	088-866-5811
Email	rinri21@kochi-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date	2020 Year 05 Month 11 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	If specific HLA genotype are clarified in ACTH deficiency patients due to PD1-Ab treatment, it's useful to understand the pathogenic mechanisms in PD1-induced ACTH deficiency. We collect all the patients in line with criteria for selection who are treated in our hospital from May 2020 to March 2023.

Management information
Registered date	2020 Year 04 Month 26 Day
Last modified on	2020 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045906

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.