Transperineal Ultrasonography in the Diagnosis and Monitoring of Rectal Inflammation in Ulcerative Colitis: A Validated AI Approach: international multicenter study ("TPUSCORE" (TransPerineal Ultrasound SCOring for Rectal Evaluation in UC))

Transperineal Ultrasonography in the Diagnosis and Monitoring of Rectal Inflammation in Ulcerative Colitis: A Validated AI Approach: international multicenter study ("TPUSCORE" (TransPerineal Ultrasound SCOring for Rectal Evaluation in UC)) - TPUSCORE study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057596

Enrollment

264

Registered

2025-04-11

Start date

2025-03-24

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with ulcerative colitis Patients who are scheduled to initiate or modify therapy, or are under observation and will undergo endoscopy and intestinal ultrasound Patients aged 15 years or older (including minors in some institutions)

Exclusion criteria

Exclusion criteria: Patients with a history of total colectomy Patients who are pregnant or breastfeeding Patients deemed inappropriate by the investigator

Design outcomes

Primary

Measure	Time frame
Endoscopic remission at week 24 (Ulcerative Colitis Endoscopic Index of Severity =0, 1)	—

Secondary

Measure	Time frame
Endoscopic improvement at week 24, defined as Mayo Endoscopic Subscore zero or one Clinical remission, defined as patient-reported outcome one or less and rectal bleeding subscore zero Histological healing, defined as Nancy index one or less and Geboes score two point one or less Assessment of the predictive ability of changes in TPUS parameters at week two for clinical and endoscopic outcomes at week twenty-four Evaluation of the relationship between TPUS parameters and changes in UCEGS and UCEIS	—

Measure

Time frame

Endoscopic improvement at week 24, defined as Mayo Endoscopic Subscore zero or one Clinical remission, defined as patient-reported outcome one or less and rectal bleeding subscore zero Histological healing, defined as Nancy index one or less and Geboes score two point one or less Assessment of the predictive ability of changes in TPUS parameters at week two for clinical and endoscopic outcomes at week twenty-four Evaluation of the relationship between TPUS parameters and changes in UCEGS and UCEIS

—

Countries

Japan,North America

Contacts

Public ContactShintaro Sagami

Kitasato University Kitasato Institute Hospital Center for Advanced IBD Research and Treatment

jaken1013@gmail.com0334446161

Outcome results