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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
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 | 2020/10/26 |
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
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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 |
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Condition | ||
Condition | ACTH deficiency | |
Classification by specialty |
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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
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Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
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Dynamic allocation | |
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Blocking | |
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Eligibility | ||||
Age-lower limit |
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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 |
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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 |
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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 | |
Institute | Kochi University |
Institute | |
Department |
Funding Source | |
Organization | Others |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Recruitment status | Enrolling by invitation | ||||||
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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 |
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Last modified on |
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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 | |
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Research case data | |
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