Comparison Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With intestinalBOweL Diseases

NCT06793124 | Recruiting

• 1 other identifier: CYTO-BOLD
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Observational, single-center, non-pharmacological, prospective study of adult patients affected by Inflammatory Bowel Disease (IBD) with an ongoing disease exacerbation requiring hospitalization

Conditions

Cytomegalovirus (CMV); Inflammatory Bowel Disease (IBD)

Keywords

Cytomegalovirus (CMV); Inflammatory Bowel Disease (IBD); PCR; Tissue biopsy

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance of CMV-DNA Quantification in Blood and Fecal Samples Compared to Immunohistochemistry on Biopsy for CMV Infection Diagnosis

  Evaluation of the diagnostic performance of different methods used for the diagnosis of CMV infection, i.e. CMV-DNA on blood and CMV-DNA on fecal samples - comparing them with the gold standard, i.e. immunohistochemical investigation on biopsy sample in patients affected by IBD with clinical worsening requiring hospitalization

  Each samples taken from the patients will be tested through study completion (average of 2 year)

Secondary Outcomes (5)

• Concordance Between Positive/Borderline Immunohistochemistry and PCR for CMV on Biopsy Samples

  Each samples taken from the patients will be tested through study completion (average of 2 year)

• Severity of Immunohistochemical Pattern and Its Relationship with Clinical Evolution

  Each samples taken from the patients will be tested through study completion (average of 2 year)

• Viral Load in Biopsy Samples and Its Correlation with Clinical Outcomes

  Each samples taken from the patients will be tested through study completion (average of 2 year)

• Impact of Antiviral Treatment on Clinical Evolution

  Each samples taken from the patients will be tested through study completion (average of 2 year)

• Clinical Evolution at 30 Days in Patients With and Without CMV Organ Disease

  At the follow-up at 30 days (through study completion, an average of 2 year)

Study Arms (1)

Adult patients with inflammatory bowel disease (IBD)

Adult patients with inflammatory bowel disease (IBD) who undergo colonic biopsy for recurrence of the underlying disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with inflammatory bowel disease (IBD), either outpatients or requiring hospital admission, who undergo colonic biopsy for recurrence of the underlying disease, will be screened for inclusion

You may qualify if:

• Patients aged ≥18 years with Inflammatory Bowel Disease (IBD) with worsening of IBD-related symptoms requiring hospital admission
• Signing of informed consent
• Performed endoscopic biopsies to confirm/exclude CMV organ disease

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* serum samples for CMV-DNA * stool samples for CMV-DNA

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Matteo Rinaldi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Rinaldi, MD

CONTACT

+390512144302; matteo.rinaldi23@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: January 27, 2025
• Study Start: April 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

IT (1)