UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058147 |
|---|---|
| Receipt number | R000066459 |
| Scientific Title | Patient registry of inflammatory bowel disease to investigate the clinical course and predictors of treatment outcomes : A multicenter observational study (INSIGHT study) |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/10 22:58:43 |
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Basic information
Public title
Patient registry of inflammatory bowel disease to investigate the clinical course and predictors of treatment outcomes : A multicenter observational study (INSIGHT study)
Acronym
INSIGHT study
Scientific Title
Patient registry of inflammatory bowel disease to investigate the clinical course and predictors of treatment outcomes : A multicenter observational study (INSIGHT study)
Scientific Title:Acronym
INSIGHT study
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to clarify the treatment course and actual conditions of IBD through the creation of a large-scale database, to examine factors that influence the effectiveness of IBD treatment, and to provide useful information for treatment selection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy rates of newly introduced drugs in the short term (2 weeks and 2 months), mid-term (3 months and 6 months), and long term (1 year, 3 years, and 5 years), treatment continuation rates, and factors correlated with these
Key secondary outcomes
Rates of new treatment introduction, hospitalization, and surgery in newly diagnosed cases, and factors correlating with them
Relapse and reoperation rates in postoperative cases, and factors correlating with them
Efficacy rates, endoscopic improvement rates, and continuation rates of 1st-line, 2nd-line, and 3rd-line treatments, and factors correlating with them
Endoscopic remission achievement rate, treatment continuation rate, hospitalization rate, and surgery rate for 2nd-line treatment in cases who achieved clinical remission with 1st-line treatment
Efficacy of anti-TNF antibody preparations, IL12/23 (23) antibody preparations, and JAK inhibitors in cases with a history of anti-TNF antibody treatment, and efficacy after anti-TNF treatment and molecular targeted drug treatment Comparison with cases without treatment
Efficacy of anti-TNF antibody preparations and IL12/23 (23) antibody preparations in cases with a history of IL12/23 (23) antibody preparation treatment, comparison with cases after anti-TNF treatment and without molecular targeted drug treatment
Efficacy of anti-TNF antibody preparations and IL12/23 (23) antibody preparations in cases with a history of JAK treatment, comparison with cases without molecular targeted drug treatment
Efficacy of anti-TNF antibody preparations, IL12/23 (23) antibody preparations, and JAK inhibitors in cases with a history of VDZ treatment, comparison with cases without molecular targeted drug treatment
Endoscopic findings, scores, and clinical factors correlated with prognosis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[New onset group]
Meet all of the following (1) to (3)
(1) Cases newly diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) at Nagoya University Hospital or any research institute after January 1, 2013
(2) Age 18 or older at the time of new onset
(3) Gender does not matter.
[New treatment group]
(1) Patients who started treatment with tacrolimus, infliximab, adalimumab, golimumab, tofacitinib, vedolizumab, cyclosporine, ustekinumab, cytapheresis, steroids, azathioprine, 5-ASA, local therapy, filgotinib, upadacitinib, mikilizumab, carotegrast methyl, risankizumab, zentacort, colletiment, osamonide, or guselkumab at Nagoya University Hospital or any research institute on or after January 1, 2013.
(2) Patients must be 18 years of age or older at the time of starting new treatment.
(3) Gender does not matter.
[Postoperative follow-up group]
Meet all of the following (1) to (3)
(1) Patients who underwent surgical treatment for inflammatory bowel disease at Nagoya University Hospital or at each research institute during the study period from January 1, 2013 onwards
(2) Patients must be aged 18 or older at the time of surgical treatment.
(3) Gender does not matter.
[Endoscopy group]
Meet all of the following (1) to (3)
(1) Patients who underwent endoscopic examination for inflammatory bowel disease at Nagoya University Hospital or at each research institute during the study period from January 1, 2013 onwards
(2) Patients must be aged 18 or older at the time of endoscopic examination.
(3) Gender does not matter.
Key exclusion criteria
[New onset group]
-None
[New treatment introduction group]
-None
[Postoperative follow-up observation group]
-None
[Endoscopy group]
-None
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Masanao |
| Middle name | |
| Last name | Nakamura |
Organization
Nagoya University Hospital
Division name
Department of Endscopy
Zip code
4668560
Address
65 Tsurumai, Showa-ku, Nagoay city, Aich prefecture
TEL
0527442172
nakamura.masanao.u0@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsunaki |
| Middle name | |
| Last name | Sawada |
Organization
Nagoya University Hospitao
Division name
Department of Endoscopy
Zip code
4668560
Address
65 Tsurumai, Showa-ku, Nagoay city, Aich prefecture
TEL
09035532957
Homepage URL
sawada.tsunaki.d5@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Self-Procurement
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
Nagoya University Clinical Research Review Board
Address
Tsurumai 65, Showa-ku, Nagoya city, Aichi prefecture
Tel
0527442172
echics@med.nagoya-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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2033 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At each facility, newly developed cases, cases in which new treatments were introduced, and cases undergoing surgery are extracted from the electronic medical records, and the data is then entered into an Excel data collection sheet by viewing the medical records.
Management information
Registered date
| 2025 | Year | 06 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066459
