Cytomegalovirus (CMV)CYTO-BOLDNCT06793124
Comparison Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With intestinalBOweL Diseases
An observational study of Cytomegalovirus (CMV) and Inflammatory Bowel Disease (IBD), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Observational, single-center, non-pharmacological, prospective study of adult patients affected by Inflammatory Bowel Disease (IBD) with an ongoing disease exacerbation requiring hospitalization Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus (CMV), Inflammatory Bowel Disease (IBD)
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 2 Apr 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Matteo Rinaldi, MD, +390512144302, matteo.rinaldi23@aosp.bo.it
About this study
Official title: Comparison of Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With Intestinal BOweL Diseases
Observational, single-center, non-pharmacological, prospective study of adult patients affected by Inflammatory Bowel Disease (IBD) with an ongoing disease exacerbation requiring hospitalization
Read the detailed description
Patients with chronic inflammatory bowel disease (IBD) are subject to an increased risk of infectious events. This is secondary in part to an intrinsic dysregulation of the immune system, in part to the increasingly frequent need to subject the patient to immunomodulatory therapies for the management of the underlying disease. In this context, it is very difficult from a clinical point of view to be able to demonstrate a concomitant intestinal cytomegalovirus (CMV) organ disease, since the symptoms are often nonspecific or overlapping. Following the guidelines, since there is no well-defined cut-off for viral replication in blood, the gold standard for the diagnosis of intestinal CMV disease remains organ-specific biopsy with immunohistochemical research of the included nuclei. However, at the moment there are no reliable findings for this method that can distinguish a clinically insignificant reactivation from a true organ disease. However, plasma CMV viremia measurement is generally recommended in this setting since active replication in blood could be an epiphenomenon of organ disease. Similarly, some studies have shown a correlation between CMV gastroenteritis and detection of CMV-DNA in fecal samples. Furthermore, several methods have been developed in recent years, and their diagnostic yield has not yet been fully defined. The evaluation of viral load on tissue biopsy by PCR is a method that is gaining ground, and currently the guidelines suggest it in association with immunohistochemistry itself. Some authors suggest a cut-off of 250 cp/mg of tissue to define organ disease. In this setting, the initiation of a specific antiviral treatment remains non-standardized, and it presents expected side effects, primarily bone marrow suppression. However, in several studies, an increased need for surgery for uncontrolled underlying disease has been found in patients with CMV organ disease who are not treated promptly.
From a clinical point of view, in patients who have worsening symptoms related to IBD, being able to identify early markers able to predict CMV colonic organ disease is of crucial importance, since early specific treatment could increase the chances of a favorable outcome, sparing the patient the need for abdominal surgery. In this context, plasma and fecal CMV-DNA dosage represents a rapid diagnostic method, with a turn-over of about 24 hours, which could be an epiphenomenon of the colonic disease itself.
The primary objective of the study is to evaluate the diagnostic performance of different methods used for the diagnosis of CMV infection, namely CMV-DNA on blood and CMV-DNA on fecal samples - comparing them with the gold standard, namely immunohistochemical investigation on biopsy sample in patients affected by IBD with clinical worsening requiring hospitalization.
- Keywords
- Cytomegalovirus (CMV), Inflammatory Bowel Disease (IBD), PCR, Tissue biopsy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with inflammatory bowel disease (IBD) | Adult patients with inflammatory bowel disease (IBD) who undergo colonic biopsy for recurrence of the underlying disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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)
Measured: 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
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.)
Measured: Each samples taken from the patients will be tested through study completion (average of 2 year)
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.)
Measured: 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
Evaluate the clinical evolution of patients with and without Cytomegalovirus (CMV) organ disease at 30 days. Clinical response will be defined by the normalization of bowel function (i.e., normalization of daily evacuation frequency) and the disappearance of systemic symptoms, such as fever, if present. Clinical refractoriness will be assessed based on the failure to achieve these clinical improvements and the potential need for unplanned major abdominal rescue surgery by the end of the follow-up period (+30 days).
The comparison will include:
Clinical Response: Improvement in bowel function and resolution of systemic symptoms.
Clinical Refractoriness: Lack of improvement and requirement for unplanned major abdominal surgery.
Measured: At the follow-up at 30 days (through study completion, an average of 2 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start2 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus (CMV)Studies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Rinaldi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793124
- Sponsor's protocol ID
- CYTO-BOLD
- Acronym
- CYTO-BOLD
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With Intestinal BOweL Diseases
- ClinicalTrials.gov ID
- NCT06793124
- Acronym / sponsor ID
- CYTO-BOLD / CYTO-BOLD
- Keywords
- Cytomegalovirus (CMV), Inflammatory Bowel Disease (IBD), PCR, Tissue biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational, single-center, non-pharmacological, prospective study of adult patients affected by Inflammatory Bowel Disease (IBD) with an ongoing disease exacerbation requiring hospitalization
Detailed description
Patients with chronic inflammatory bowel disease (IBD) are subject to an increased risk of infectious events. This is secondary in part to an intrinsic dysregulation of the immune system, in part to the increasingly frequent need to subject the patient to immunomodulatory therapies for the management of the underlying disease. In this context, it is very difficult from a clinical point of view to be able to demonstrate a concomitant intestinal cytomegalovirus (CMV) organ disease, since the symptoms are often nonspecific or overlapping. Following the guidelines, since there is no well-defined cut-off for viral replication in blood, the gold standard for the diagnosis of intestinal CMV disease remains organ-specific biopsy with immunohistochemical research of the included nuclei. However, at the moment there are no reliable findings for this method that can distinguish a clinically insignificant reactivation from a true organ disease. However, plasma CMV viremia measurement is generally recommended in this setting since active replication in blood could be an epiphenomenon of organ disease. Similarly, some studies have shown a correlation between CMV gastroenteritis and detection of CMV-DNA in fecal samples. Furthermore, several methods have been developed in recent years, and their diagnostic yield has not yet been fully defined. The evaluation of viral load on tissue biopsy by PCR is a method that is gaining ground, and currently the guidelines suggest it in association with immunohistochemistry itself. Some authors suggest a cut-off of 250 cp/mg of tissue to define organ disease. In this setting, the initiation of a specific antiviral treatment remains non-standardized, and it presents expected side effects, primarily bone marrow suppression. However, in several studies, an increased need for surgery for uncontrolled underlying disease has been found in patients with CMV organ disease who are not treated promptly.
From a clinical point of view, in patients who have worsening symptoms related to IBD, being able to identify early markers able to predict CMV colonic organ disease is of crucial importance, since early specific treatment could increase the chances of a favorable outcome, sparing the patient the need for abdominal surgery. In this context, plasma and fecal CMV-DNA dosage represents a rapid diagnostic method, with a turn-over of about 24 hours, which could be an epiphenomenon of the colonic disease itself.
The primary objective of the study is to evaluate the diagnostic performance of different methods used for the diagnosis of CMV infection, namely CMV-DNA on blood and CMV-DNA on fecal samples - comparing them with the gold standard, namely immunohistochemical investigation on biopsy sample in patients affected by IBD with clinical worsening requiring hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with inflammatory bowel disease (IBD) | – | –Adult patients with inflammatory bowel disease (IBD) who undergo colonic biopsy for recurrence of the underlying disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Performance of CMV-DNA Quantification in Blood and Fecal Samples Compared to Immunohistochemistry on Biopsy for CMV Infection Diagnosis
Time frame: Each samples taken from the patients will be tested through study completion (average of 2 year)
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
5 secondary outcomes
Concordance Between Positive/Borderline Immunohistochemistry and PCR for CMV on Biopsy Samples
Time frame: 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
Time frame: 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
Time frame: Each samples taken from the patients will be tested through study completion (average of 2 year)
Impact of Antiviral Treatment on Clinical Evolution
Time frame: 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
Time frame: At the follow-up at 30 days (through study completion, an average of 2 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matteo Rinaldi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus (CMV) and Inflammatory Bowel Disease (IBD), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Rinaldi, MD (+390512144302, matteo.rinaldi23@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of CMV-DNA Quantification in Blood and Fecal Samples Compared to Immunohistochemistry on Biopsy for CMV Infection Diagnosis (time frame: Each samples taken from the patients will be tested through study completion (average of 2 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.