UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058198 |
|---|---|
| Receipt number | R000066469 |
| Scientific Title | Efficacy of Anti-Integrin avb6 Autoantibody for Immune Checkpoint Inhibitor-Induced Colitis |
| Date of disclosure of the study information | 2025/06/23 |
| Last modified on | 2025/06/16 20:01:15 |
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Basic information
Public title
Efficacy of Anti-Integrin avb6 Autoantibody for Immune Checkpoint Inhibitor-Induced Colitis
Acronym
avb6-ICI Colitis Trial
Scientific Title
Efficacy of Anti-Integrin avb6 Autoantibody for Immune Checkpoint Inhibitor-Induced Colitis
Scientific Title:Acronym
avb6-ICI Colitis Trial
Region
| Japan |
Condition
Condition
Immune Checkpoint Inhibitor-Induced Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the Utility of Anti-Integrin avb6 Antibodies in Immune Checkpoint Inhibitor-Induced Colitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association Between Serum Anti-Integrin avb6 Antibody Titers and Steroid Responsiveness and Relapse in Patients with Immune Checkpoint Inhibitor-Induced Colitis
Key secondary outcomes
Association Between Serum Anti-Integrin avb6 Antibody Titers and Disease Activity
Association Between Serum Anti-Integrin avb6 Antibody Titers and Intestinal Lesions
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 20 years old or more
2. Patients who developed colitis after receiving anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody therapy for malignancy
3. Patients diagnosed with immune checkpoint inhibitor-induced colitis, confirmed through colonoscopy, including histopathological examination
4. Consent for this trial
Key exclusion criteria
1. Patients with a history of Crohn's disease or ulcerative colitis
2. Patients with infectious enteritis caused by pathogenic microorganisms such as Clostridioides difficile, Campylobacter jejuni, or Cytomegalovirus
3. Patients deemed inappropriate for inclusion by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Inoue |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Gastroenterology
Zip code
650-0047
Address
2-1-1, Minatojimaminami-machi, Chuo-ku, Kobe, Hyogo
TEL
078-302-4321
satoin@kcho.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Morihisa |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Gastroenterology
Zip code
650-0047
Address
2-1-1, Minatojimaminami-machi, Chuo-ku, Kobe, Hyogo
TEL
078-302-4321
Homepage URL
yoshiki_morihisa@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kobe City Medical Center General Hospital
Address
2-1-1, Minatojimaminami-machi, Chuo-ku, Kobe, Hyogo
Tel
078-302-4321
N/A
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
| 2025 | Year | 06 | Month | 23 | 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
| 2025 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066469
