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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Adult patients with inflammatory bowel disease (IBD)

Trial outcomes

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

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

Secondary outcomes

1

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

Verify the concordance between positive/borderline immunohistochemistry (microscopic examination using specific antibodies to detect the presence of CMV) on biopsy sample and PCR (Polymerase Chain Reaction) for CMV on the sample itself

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

Severity of Immunohistochemical Pattern and Its Relationship with Clinical Evolution

Verify if there is a relationship between the severity of the immunohistochemical pattern and clinical evolution and/or the need for major abdominal surgery (colectomy, stoma placement, etc.). Measurement Tools: Immunohistochemistry (Analysis of the severity of the immunohistochemical pattern in biopsy samples, focusing on CMV-related markers); Clinical Assessment (Evaluation of clinical evolution, including the need for major abdominal surgeries)

Time frame
Each samples taken from the patients will be tested through study completion (average of 2 year)
3

Viral Load in Biopsy Samples and Its Correlation with Clinical Outcomes

Verify whether there is a relationship between viral load on biopsy sample and clinical evolution and/or need for major abdominal surgery (colectomy, stoma placement, etc.) Correlation between viral load in biopsy samples and clinical outcomes and/or implications for major abdominal surgery (colectomy, stoma placement, etc.)

Time frame
Each samples taken from the patients will be tested through study completion (average of 2 year)
4

Impact of Antiviral Treatment on Clinical Evolution

Evaluate the impact of an antiviral treatment on clinical evolution and/or need for major abdominal surgery (colectomy, stoma placement, etc.)

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

Other outcomes

Sponsors and contacts

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