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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040239
Receipt No. R000045906
Scientific Title HLA analysis in ACTH deficiency due to immune-related adverse events of PD1 antibody
Date of disclosure of the study information 2020/05/11
Last modified on 2020/04/26

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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


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