Unique ID issued by UMIN | UMIN000036492 |
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Receipt number | R000041550 |
Scientific Title | Study of homology and dissimilarity between immune-related colitis and ulcerative colitis |
Date of disclosure of the study information | 2019/04/17 |
Last modified on | 2024/04/15 11:23:23 |
Study of homology and dissimilarity between immune-related colitis and ulcerative colitis
Study of immune-related colitis
Study of homology and dissimilarity between immune-related colitis and ulcerative colitis
Study of immune-related colitis
Japan |
immune-related colitis
Gastroenterology |
Malignancy
NO
To reveal the pathological and immunological homology and difference between colitis as immune-related adverse events after administration of anti CTLA-4 antibody, anti PD-1 antibody or anti PD-L1 antibody, and inflammatory bowel disease.
Others
Not defined
Exploratory
Not applicable
Pathological findings and endoscopic findings of immune-related colitis.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
The subjects must satisfy the following conditions.
1. Written informed consent must be obtained from patients.
2. Patients must be over 20 years old.
3. Excluding temporary use for testing or prophylaxis, patients have not been taken treatment with steroid or immunosuppressant continuously within 14 days before administration.
irAE colitis group must satisfy the following conditions.
1. Patients have been diagnosed with cancer, and treated with immune checkpoint inhibitors.
2. Patients with >= Grade 2 colitis, and infectious colitis or drug-induced colitis were denied.
Ulcerative colitis group must satisfy the following conditions.
1. Patients with moderate or severe ulcerative colitis, and who had not received any systemic steroid therapy or anti-TNF alpha antibody within 6 months.
The following patients must be excluded:
1) Patients who have severe psychiatric disease.
2) Patients who are considered to be difficult to take a colonoscopy for their condition.
3) Patients who are taking two or more antithrombotic drugs and it is difficult to withdraw them for endoscopic biopsy.
4) Patients who are suspected of infectious enterocolitis, and taking some antibiotics.
5) Patients who are judged inappropriate for entry to this clinical trial by doctors.
irAE-colitis group
1) Patients who suffered colitis within 4 weeks after administration of immune checkpoint inhibitors.
Ulcerative colitis group
1) Not defined.
40
1st name | Yasuo |
Middle name | |
Last name | Hamamoto |
Keio University School of Medicine
Divison of Gastroenterology and Hepatology, Department of Internal Medicine
1600016
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-3353-1211
yashmmt1971@gmail.com
1st name | Akihiko |
Middle name | |
Last name | Chida |
Keio University School of Medicine
Divison of Gastroenterology and Hepatology, Department of Internal Medicine
1600016
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-3353-1211
akihiko.chida.214@keio.jp
Keio University
None
Self funding
Institutional Review Board, Keio University School of Medicine
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
NO
2019 | Year | 04 | Month | 17 | Day |
Unpublished
Open public recruiting
2019 | Year | 03 | Month | 29 | Day |
2019 | Year | 03 | Month | 29 | Day |
2019 | Year | 03 | Month | 29 | Day |
2024 | Year | 03 | Month | 30 | Day |
None
2019 | Year | 04 | Month | 12 | Day |
2024 | Year | 04 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041550
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