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SOnographic evaLuation for Inflammatory bowel disease in Daily practice (SOLID) Study

SOnographic evaLuation for Inflammatory bowel disease in Daily practice (SOLID) Study - SOLID Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000050970
Enrollment
100
Registered
2023-05-05
Start date
2023-05-15
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

Sponsors

Kyorin University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Subjects diagnosed with UC. - Subjects who plan to take endoscopic examinations for assessing the disease activity of UC in daily practice. - Subjects who are 16 years old or older when providing written consent. - Subjects who understand, decide to take part in this study and provide written consent by themselves. Minors need consent from themselves as well as their guardians.

Exclusion criteria

Exclusion criteria: - Subjects who had total or partial colectomy or plan to take such surgery when providing written consent. - Subjects diagnosed with proctitis or an undetermined disease type. - Subjects with suspected concomitant colitis, e.g. infections enteritis, diverticulitis, and ischemic colitis (taking colonoscopy for examining other etiologies). - Subjects with an emergent, critical condition of UC.

Design outcomes

Primary

MeasureTime frame
Estimation accuracy of a scoring system based on IUS findings developed in this study (SOLID-UC index) for endoscopic remission at 6 months after starting the remission induction therapy.

Secondary

MeasureTime frame
- Intra-/inter-observer agreement rates of each sonographic parameter in each segment of the colon and in the most severely affected part of the colon - Minimal important change of SOLID-UC index - Correlation between changes in SOLID-UC index, in its parameters, and in endoscopic scores - Assessment of reliability and measurement error of SOLID-UC index - Comparison of the predictive accuracy of SOLID-UC index, partial Mayo score, Lichtiger index, and biomarkers for endoscopic remission at 6 months after remission induction treatment

Countries

Japan

Contacts

Public ContactJun Miyoshi

Kyorin University School of Medicine Department of Gastroenterology and Hepatology

jmiyoshi@ks.kyorin-u.ac.jp0422-47-5511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026