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

Email

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


Email

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

Email

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