immune-related colitis
Conditions
Interventions
None listed
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological findings and endoscopic findings of immune-related colitis. | — |
Countries
Japan
Contacts
Public ContactAkihiko Chida
Keio University School of Medicine Divison of Gastroenterology and Hepatology, Department of Internal Medicine
Outcome results
None listed