- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07637045
Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity (PGE-MUM_UC)
Urinary Prostaglandin E-Major Metabolite (PGE-MUM) Discriminates Disease Activity in Ulcerative Colitis: A Cross-Sectional Study From Egypt
Ulcerative colitis (UC) is a chronic inflammatory bowel disease that requires regular monitoring of disease activity. Currently, assessment depends on invasive colonoscopy or clinical scores that may not accurately reflect intestinal inflammation. This study aims to evaluate whether urinary Prostaglandin E-Major Metabolite (PGE-MUM) can serve as a non-invasive biomarker to discriminate disease activity in patients with ulcerative colitis.
This cross-sectional study will be conducted at Al-Rajhi University Hospital, Assiut University, Egypt.This study plans to enroll 114 adult patients (≥18 years) with confirmed UC diagnosis, divided into two equal groups: active disease and remission (57 patients each). Disease activity will be assessed using the Mayo Endoscopic Score (MES) and Clinical Activity Index (CAI). Urine samples will be collected from all participants to measure PGE-MUM levels. Blood samples will be tested for CRP, CBC, albumin, and creatinine. Colonoscopy with biopsy will be performed for endoscopic scoring and histopathological assessment using Geboes score.
The primary outcome is to establish urinary PGE-MUM as a validated discriminatory biomarker for distinguishing active disease from remission in Egyptian patients with UC. Secondary outcomes include comparing PGE-MUM with CRP, determining the optimal cut-off value, and correlating PGE-MUM levels with MES and Geboes score.
If successful, urinary PGE-MUM could provide a simple, non-invasive, and cost-effective method for monitoring UC activity in the Egyptian healthcare setting, reducing the need for frequent colonoscopies and overcoming cultural barriers associated with stool collection.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Randa Mahrous Roshdy, Master of Internal Medicine
- Telefonnummer: +201021584548
- E-post: randa011188@med.aun.edu.eg
Studer Kontakt Backup
- Navn: Ahmed Abd El Fadil Maghraby, MD
- Telefonnummer: +201122871357
- E-post: dr_magraby@aun.edu.eg
Studiesteder
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Asyut, Egypt, 71515
- Al-Rajhi University Hospital
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Ta kontakt med:
- Randa Mahrous Roshdy, MSc
- Telefonnummer: +201021584548
- E-post: randa011188@med.aun.edu.eg
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Underetterforsker:
- Randa Mahrous Roshdy, MSc
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Adult patients aged ≥18 years
- Confirmed diagnosis of Ulcerative Colitis based on clinical, endoscopic, and histopathological criteria
- Active disease (Mayo Endoscopic Score 2-3, Clinical Activity Index ≥4) OR remission (Mayo Endoscopic Score 0-1, Clinical Activity Index ≤3)
- Willing and able to provide written informed consent
Exclusion Criteria:
- Patients with other types of colitis (e.g., Crohn's disease, infectious colitis, ischemic colitis)
- History of colectomy
- Current smokers
- Chronic lung disease
- Malignancy
- Use of laxatives or NSAIDs within 2 weeks prior to enrollment
- Chronic kidney disease
- Pregnancy or lactation
- Active infection
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Active UC Group
Patients with active ulcerative colitis (Mayo Endoscopic Score 2-3, Clinical Activity Index ≥4)
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Remission UC
Patients with ulcerative colitis in remission (Mayo Endoscopic Score 0-1, Clinical Activity Index ≤3)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Urinary PGE-MUM Levels Discriminates Disease Activity in UC
Tidsramme: At the time of enrollment (single visit, cross-sectional assessment)
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To establish urinary PGE-MUM as a validated discriminatory biomarker for distinguishing active disease from remission in Egyptian patients with ulcerative colitis.Disease activity is assessed using the Mayo Endoscopic Score (MES, 0-3; higher=worse) and Clinical Activity Index (CAI, 0-19; higher=worse).
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At the time of enrollment (single visit, cross-sectional assessment)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Correlation between PGE-MUM and CRP
Tidsramme: At enrollment
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To compare urinary PGE-MUM levels with serum C-reactive protein (CRP) levels in patients with active and remission UC. Disease activity is assessed using the Mayo Endoscopic Score (MES, 0-3; higher=worse) and Clinical Activity Index (CAI, 0-19; higher=worse). |
At enrollment
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Optimal PGE-MUM cut-off value for disease activity
Tidsramme: At enrollment
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To determine the optimal cut-off value of urinary PGE-MUM for discriminating active UC from remission using ROC curve analysis. Disease activity is assessed using the Mayo Endoscopic Score (MES, 0-3; higher=worse) and Clinical Activity Index (CAI, 0-19; higher=worse). |
At enrollment
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Correlation between PGE-MUM and Endoscopic/Histologic scores
Tidsramme: At enrollment
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The Mayo Endoscopic Score (MES) ranges from 0 to 3, with higher scores indicating more severe disease.
The Geboes histologic score ranges from 0 to 5.4, with higher scores indicating more severe inflammation.
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At enrollment
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mohamed Zain El Den Hafez, Professor, Assiut University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ASU_PhD_UC_2026_001
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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