NCT07246460 Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).
| NCT ID | NCT07246460 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Crohn's Disease of Both Small and Large Intestine |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-10-31 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2025-10-31 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to evaluate the response of guselkumab in adult patients with Crohn's disease (CD) as measured on intestinal ultrasound (IUS), the relative quantities of CD64 in endoscopic tissue biopsies, and the protein signature in the blood of patients with and without therapy response. The main question it aims to answer is: * What is the proportion of ileal Crohn's disease patients with and without strictures who achieve an intestinal ultrasound response? * What is the quantity of CD64 in tissue in CD patients at baseline and at week 52 with and without IUS response? * Are there proteomic signatures in blood of CD patients that respond to GUS?
Eligibility Criteria
Inclusion Criteria: Male or female, 18 to 80 years old BWT on IUS \> 3.0mm in the ileum and colonic disease permitted. Patients naïve to guselkumab. Stricture phenotype - BWT \> 3 mm, luminal apposition \< 1cm or \< 50% of adjacent normal bowel diameter, and prestenotic dilation of distal ileum. Naïve or anastomotic strictures permitted. Non-stricture phenotype- ileal CD with no evidence of stricture on IUS, computed tomography enterography (CTE), or magnetic resonance enterography (MRE), ever or fistulizing phenotype. Exclusion Criteria: Pregnancy Ileostomy or colostomy Significant obesity (BMI \> 35) Contraindications to initiating GUS such as active infection. Active malignancy within five years. Conditions with fibrosis involving other organs such as lungs, kidneys, brain, or skin.
Contact & Investigator
Cathy Lu
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT07246460 clinical trial?
This trial is open to participants of all sexes, up to 80 Years, studying Crohn's Disease of Both Small and Large Intestine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07246460 currently recruiting?
Yes, NCT07246460 is actively recruiting participants. Contact the research team at luc@ucalgary.ca for enrollment information.
Where is the NCT07246460 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT07246460 clinical trial?
NCT07246460 is sponsored by University of Calgary. The principal investigator is Cathy Lu at University of Calgary. The trial plans to enroll 90 participants.
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