UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061445 |
|---|---|
| Receipt number | R000070304 |
| Scientific Title | Multidimensional Analysis of Clinical Outcomes and Carcinogenesis in Inflammatory Bowel Disease Associated Neoplasia |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/03 09:45:13 |
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Basic information
Public title
Study on the Clinical Course and Mechanisms of Tumor Development in Inflammatory Bowel Disease
Acronym
IBD-NeoMAP
Scientific Title
Multidimensional Analysis of Clinical Outcomes and Carcinogenesis in Inflammatory Bowel Disease Associated Neoplasia
Scientific Title:Acronym
IBD-NeoMAP
Region
| Japan |
Condition
Condition
Ulcerative Colitis Associated Neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the clinical course and long term outcomes of ulcerative colitis associated neoplasia (UCAN), and to investigate its carcinogenic mechanisms through integrated endoscopic, pathological, and molecular analyses. In addition, this study aims to compare the outcomes of endoscopic and surgical treatments in order to provide evidence for optimizing surveillance and therapeutic strategies for UCAN.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence-free survival (RFS)
Defined as the time from the date of initial treatment to the date of first documented recurrence or death from any cause. Recurrence includes local recurrence, metachronous lesions, and distant recurrence.
Key secondary outcomes
Overall survival (OS)
Defined as the time from the date of initial treatment to death from any cause.
Local recurrence rate
The proportion of patients who develop neoplastic recurrence at the initial treatment site.
Incidence of metachronous lesions
The proportion of patients who develop newly detected neoplastic lesions at sites different from the initial lesion after initial treatment.
Rate of progression to carcinoma
The proportion of patients who progress from dysplasia or high-grade dysplasia to carcinoma during follow-up.
Rate of additional treatment
The proportion of patients requiring additional endoscopic or surgical treatment after initial treatment.
Rate of conversion to surgery
The proportion of patients who undergo colectomy or proctocolectomy after initial endoscopic treatment.
Treatment-related adverse event rate
The proportion of patients who develop treatment-related adverse events, including bleeding, perforation, infection, or anastomotic leakage.
Associations between clinicopathological/molecular factors and clinical outcomes
Associations of age, sex, disease duration, lesion location, tumor size, macroscopic type, histological type, grade of dysplasia, immunohistochemical findings, and genetic alterations with recurrence, progression to carcinoma, and survival.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older during the study period.
Patients with gastrointestinal neoplasia associated with ulcerative colitis who underwent surgical resection or endoscopic resection.
Key exclusion criteria
Patients who opt out of participation after public disclosure of the study (by themselves or their legally authorized representatives).
Patients with insufficient clinical data or specimens for analysis.
Patients deemed inappropriate for inclusion by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | YUDAI |
| Middle name | |
| Last name | OTSUKI |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
113-0034
Address
1-5-29 Yushima, Bunkyo-ku, Tokyo 113-0034, Japan
TEL
03-3813-3111
y.otsuki.uz@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | YUDAI |
| Middle name | |
| Last name | OTSUKI |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
113-0034
Address
1-5-29 Yushima, Bunkyo-ku, Tokyo 113-0034, Japan
TEL
09058459505
Homepage URL
y.otsuki.uz@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University Urayasu Hospital Tokyo Rinkai Hospital Tokyo Yamate Medical Center Japan Community Health Care Organization
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
1-5-29 Yushima, Bunkyo-ku,Tokyo 113-0034, Japan
Tel
09058459505
y.otsuki.uz@juntendo.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
| 2026 | Year | 05 | Month | 11 | 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
| 2025 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective observational cohort study.Patients with ulcerative colitis associated neoplasia who underwent endoscopic or surgical resection between January 1, 2011 and October 31, 2025 will be included.Clinical data will be retrospectively collected from electronic medical records and pathological specimens to evaluate long-term outcomes.The primary outcome is recurrence-free survival.Comparisons between endoscopic and surgical treatment groups, as well as analyses of prognostic factors, will be performed.
Management information
Registered date
| 2026 | Year | 05 | Month | 03 | Day |
Last modified on
| 2026 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070304
