Intestinal ultrasound to predict relapse in Crohn's disease patients in deep remission.
Official title: Clinical Value of Intestinal Ultrasound in Predicting Clinical Relapse in Crohn's Disease Patients in Deep Remission: a Multicenter Prospective Observational Study
Run by Nanfang Hospital, Southern Medical University · NCT07539727 · Data updated 2026-11-12
This project will try to see if a noninvasive transabdominal ultrasound can predict relapses in adults with Crohn's disease who are currently in deep remission.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | January 1, 2029 |
| Registry record updated | April 20, 2026 |
| Trial ID | NCT07539727 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with a confirmed diagnosis of Crohn's disease who have documented deep remission by endoscopy and complete clinical and laboratory records, plus a color Doppler intestinal ultrasound performed within one week of endoscopy, are ideal candidates.
✕Probably not a fit
Patients with active disease, concomitant colorectal cancer, severe cardiopulmonary or renal dysfunction, pregnant or lactating women, those outside the eligible age range, or those who changed maintenance therapy upon remission may not benefit from the study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter prospective observational project followed adults with Crohn's disease in deep remission for 18 months to determine whether transabdominal intestinal ultrasound findings predict clinical relapse. Participants had a color Doppler intestinal ultrasound performed within one week before or after endoscopy and comprehensive clinical and laboratory data (CBC, liver and kidney tests, CRP, ESR) recorded. Investigators correlated ultrasound features with endoscopic remission status and subsequent clinical outcomes during follow-up. No investigational treatments were administered and clinical management was left to treating physicians.
Why it matters
Potential benefit: If successful, this could allow doctors to use a painless, radiation-free ultrasound to identify patients at higher risk of relapse and tailor monitoring or therapy without relying on frequent endoscopy.
How similar studies have gone: Previous studies have shown good agreement between intestinal ultrasound and endoscopic measures of disease activity, but there is limited prior evidence specifically proving its value for long-term prognosis.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients previously diagnosed with Crohn's disease via endoscopy and histopathology at other hospitals or at our institution; patients aged 18-70 years; Complete clinical data and biochemical parameters are available for the week before and after endoscopy, including comprehensive patient demographics and laboratory indicators such as complete blood count, liver function, kidney function, CRP, and ESR; a color Doppler ultrasound of the intestines was performed at our hospital within one week before or after endoscopy, and the relevant records are complete; patients assessed to have achieved deep remission based on endoscopic and other data. Exclusion Criteria: * Patients with concomitant colorectal cancer; patients with severe cardiovascular, respiratory, or urinary dysfunction; pregnant or lactating women; patients younger than 16 or older than 70 years of age; patients who changed their maintenance therapy regimen upon achieving deep remission; patients with incomplete medical records, such as color Doppler ultrasound of the intestines.
Where it's running
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NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.