Study on the Clinical Course and Mechanisms of Tumor Development in Inflammatory Bowel Disease

Multidimensional Analysis of Clinical Outcomes and Carcinogenesis in Inflammatory Bowel Disease Associated Neoplasia - IBD-NeoMAP

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061445

Enrollment

100

Registered

2026-05-11

Start date

2025-11-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis Associated Neoplasia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactYUDAI OTSUKI

Juntendo University Hospital Department of Gastroenterology

y.otsuki.uz@juntendo.ac.jp09058459505

Outcome results