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 |
Patient registry of inflammatory bowel disease to investigate the clinical course and predictors of treatment outcomes : A multicenter observational study (INSIGHT study)
INSIGHT study
Patient registry of inflammatory bowel disease to investigate the clinical course and predictors of treatment outcomes : A multicenter observational study (INSIGHT study)
INSIGHT study
Japan |
Inflammatory bowel disease
Gastroenterology |
Others
NO
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.
Safety,Efficacy
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
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
Observational
18 | years-old | <= |
Not applicable |
Male and Female
[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.
[New onset group]
-None
[New treatment introduction group]
-None
[Postoperative follow-up observation group]
-None
[Endoscopy group]
-None
10000
1st name | Masanao |
Middle name | |
Last name | Nakamura |
Nagoya University Hospital
Department of Endscopy
4668560
65 Tsurumai, Showa-ku, Nagoay city, Aich prefecture
0527442172
nakamura.masanao.u0@f.mail.nagoya-u.ac.jp
1st name | Tsunaki |
Middle name | |
Last name | Sawada |
Nagoya University Hospitao
Department of Endoscopy
4668560
65 Tsurumai, Showa-ku, Nagoay city, Aich prefecture
09035532957
sawada.tsunaki.d5@f.mail.nagoya-u.ac.jp
Nagoya University
Self-Procurement
Self funding
Nagoya University Clinical Research Review Board
Tsurumai 65, Showa-ku, Nagoya city, Aichi prefecture
0527442172
echics@med.nagoya-u.ac.jp
NO
2025 | Year | 06 | Month | 20 | Day |
Unpublished
Enrolling by invitation
2023 | Year | 12 | Month | 20 | Day |
2023 | Year | 12 | Month | 20 | Day |
2023 | Year | 12 | Month | 31 | Day |
2033 | Year | 12 | Month | 31 | Day |
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.
2025 | Year | 06 | Month | 10 | Day |
2025 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066459