UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050517 |
|---|---|
| Receipt number | R000057534 |
| Scientific Title | Study on the Efficacy of Remission Induction Therapy Based on Comprehensive Analysis of Colorectal Mucosa Gene Expression in Ulcerative Colitis |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/10/01 22:38:40 |
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Basic information
Public title
Prediction of therapeutic efficacy of ulcerative colitis based on gene expression in the colonic mucosa.
Acronym
Mucosal gene expression and therapeutic efficacy in ulcerative colitis
Scientific Title
Study on the Efficacy of Remission Induction Therapy Based on Comprehensive Analysis of Colorectal Mucosa Gene Expression in Ulcerative Colitis
Scientific Title:Acronym
Comprehensive colorectal mucosal gene expression in ulcerative colitis and prediction of treatment response.
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Predictors of efficacy regarding remission induction therapy for ulcerative colitis have been reported so far, especially based on clinical background, blood data, and mucosal gene expression, but a certain view has not yet been reached. The purpose of this study is to extract gene expression associated with the efficacy of subsequent therapeutic agents based on comprehensive gene expression in rectal mucosal biopsies of patients with active ulcerative colitis using artificial intelligence-based analysis methods. Until now, there have been no reports on the prediction of therapeutic efficacy in active-phase ulcerative colitis based on comprehensive gene expression analysis of the mucosa, and the results of this study will enable more detailed and accurate selection of remission-inducing therapeutic agents.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predicted effect of pre-treatment mucosal gene expression levels in subjects who achieved clinical remission/non-remission (defined as pMayo score <= 2) at week 16 after remission induction treatment
Key secondary outcomes
Comparison of pre-treatment gene expression by drug and effect used in remission induction therapy
Comparison of pre-treatment mucosal metabolome expression by drug and effect of drugs used in remission induction therapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(i) Ulcerative colitis patients seen between May 1, 2023 and September 30, 2025 with a pMayo score of 6 or higher
(ii) Patients who are able to obtain written consent for research participation of their own free will.
(iii) Patients whose age at the time of consent is between 18 and 80 years old.
(iv) Gender: any gender
(v) Inpatient/outpatient: any
Key exclusion criteria
(i) Women who are pregnant or may become pregnant
(ii) Patients after total colorectal resection
(iii) Patients whom the attending physician deems inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | KAZUHIKO |
| Middle name | |
| Last name | UCHIYAMA |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto, Japan
TEL
+81-05-251-5519
takatomo@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | KAZUHIKO |
| Middle name | |
| Last name | UCHIYAMA |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto, Japan
TEL
+81-05-251-5519
Homepage URL
k-uchi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Review Committee of Kyoto Prefectural University of Medicine
Address
465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto, Japan
Tel
+81-75-251-5337
rinri@koto.kpu-m.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
| 2023 | Year | 04 | Month | 01 | 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
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 31 | Day |
Other
Other related information
For patients with active ulcerative colitis, tissue samples are obtained from three different sites in the rectum using biopsy forceps at the time of endoscopy. Two of the tissues will be immediately immersed in RNA preservation solution and frozen for storage (1), and one will be directly placed in a tube and immediately frozen (2). (1) will be processed for RNA extraction at Kyoto Prefectural University of Medicine, and then sent to MacroGen Japan for comprehensive gene expression analysis using RNA sequence. (2) will be subjected to metabolomic analysis at the Department of Diabetes and Metabolism, Kyoto Prefectural University of Medicine. The results of RNA sequence and metabolome analysis will be analyzed by AI to extract the gene expression that predicts the efficacy of each drug for induction of remission therapy.
Management information
Registered date
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057534
