UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040239 |
|---|---|
| Receipt number | 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 | 2025/04/30 16:31:19 |
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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
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
nisiyamm@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
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
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
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
17
Results
HLA analysis is in progress.
Results date posted
| 2024 | Year | 04 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
None
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045906
