UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032854 |
|---|---|
| Receipt number | R000037463 |
| Scientific Title | Immune checkpoint inhibitors and drug-induced colitis |
| Date of disclosure of the study information | 2018/06/03 |
| Last modified on | 2019/06/05 19:11:46 |
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Basic information
Public title
Immune checkpoint inhibitors and drug-induced colitis
Acronym
Immune checkpoint inhibitors and drug-induced colitis
Scientific Title
Immune checkpoint inhibitors and drug-induced colitis
Scientific Title:Acronym
Immune checkpoint inhibitors and drug-induced colitis
Region
| Japan |
Condition
Condition
patients who are going to administered immune checkpoint inhibitor
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will clarify the frequency of endoscopic or histological colitis for immunocheckpoint inhibitor administration.
Also, we will clarify what kind of cases will cause colitis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endoscopic and microscopic colitis occurrence frequency at the sixth administration of immunity checkpoint inhibitor
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patient who is treated at Shiga Medical School Medical School affiliated hospital
2. Patient scheduled to receive an immunity checkpoint inhibitor
3. Age over 20 years old
4. Those who can acquire the consent of trial participation by voluntary intention from the principal in writing
Key exclusion criteria
1. Patients who can not obtain consent
2. Patient undergoing antithrombotic therapy
3. When polyps that were judged to be resected for adaptation at the time of the initial colonoscopy are discovered
4. Patients with brachytherapy embedded for prostate cancer treatment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Division of Clinical Nutrition
Zip code
520-2192
Address
Otsu, Seta-Tsukinowa, Shiga
TEL
0775482899
sb@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Division of Clinical Nutrition
Zip code
520-2192
Address
Otsu, Seta-Tsukinowa, Shiga
TEL
0775482899
Homepage URL
sb@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta-Tsukinowa Otsu
Tel
077-548-2544
hqmed2@belle.shiga-med.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
| 2018 | Year | 06 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
UCEIS
Riley score
calprotectin
microbiota
Management information
Registered date
| 2018 | Year | 06 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037463
