Multiparametric Ultrasound Study in Diagnosing GvHD (ECO-STEM)

August 12, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Evaluation of the Role of Multiparametric Ultrasound Study in Discriminating Among Intestinal Complications After Hematopoietic Stem Cell Transplantation. A Pilot Study.

The study evaluate the role of the use of bed-side multiparametric ultrasound study in the diagnosis of gastrointestinal acute graft-versus host disease (aGvHD) in patients underwent allogenic stem cell transplantation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Detailed Description

The literature reports various experiences on the use of shear wave elastography (SWE) in the study of the intestine, especially in patients with chronic inflammatory bowel diseases. But few data are reported on the use of the method in patients with graft versus host disease. Considering the simplicity of the method, we think it can be applied to an ultrasound study of the intestine to try to understand the potential of SWE to further define the characteristics of the intestinal segments involved.

Study population will include all patients submitted to allogenic stem cell transplantation (SCT) who developed diarrhea > 500 ml per day suggestive for aGvHD until 100 days from transplant date. Patients submitted to autologous stem cell transplant who developed diarrhea between transplant date and engraftment achievement will constitute control population as for other infectious complications assessment. Within 24-48 hours from symptoms, onset full panel of stool cultures will be performed together with Clostridium toxin assessment. Multiparametric ultrasound study will be performed at the onset of the symptoms and then weekly to monitoring intestinal changes accordingly to symptoms evolution during treatment. In the case with high suspicion for aGvHD (stool culture negative, persistent or progressive diarrhea, ultrasound imaging closely suggestive for aGvHD), as per common clinical practice, colonoscopy will be required to evaluate internal macroscopy features of the bowel and to obtain histological samples for conclusive diagnosis. In the meantime steroid therapy will be started, as per common clinical practice. The only modification of this protocol to common clinical practice is represented by the addition of a non-invasive bed-side method of evaluation of the patients with diarrhea. None of the routinely performed diagnostic and therapeutic process will be modified. All patients submitted to autologous stem cell transplant who developed diarrhea between transplant date and engraftment achievement will constitute control population. Also in this case full panel of stool culture and clostridium toxin assessment will be performed at the onset of the symptoms. Multiparametric ultrasound study will be made al symptoms onset and then weekly until symptom resolution. Multiparametric ultrasound study will be performed by expert qualified staff as following:The examinations will be performed at patient's bed, in supine position, with a MyLab™9 Platform (by Esaote corporate, Italy) system. Fasting is required.

US for bowel requires both low-frequency convex probes (3.3-5 MHz) and high-frequency (5-17 MHz) linear assay probes to increase the spatial resolution of the intestinal wall and to assess the wall diameter and wall layer.

Primary endpoint of the study is to evaluate the accuracy of bed-side multiparametric ultrasound study in the diagnosis of gastrointestinal aGvHD in patients underwent to allogenic transplant in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Secondary endpoints To assess potential associations between bed-side multiparametric ultrasound measurements weekly performed and aGvHD diagnosis in patients underwent to allogenic transplant. To assess whether bed-side multiparametric ultrasound measurements at baseline differ in distinguishing complications different from aGvHD (i.e., infectious, drug-related o neutropenic colitis) in patients underwent allogenic transplant as compared to auto-transplant

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years;
  • Submitted to first allogeneic stem cell transplant during the 12 months period of enrollment of the study;
  • Diarrhea onset between day 0 and day +100 from transplant;
  • Signed informed consent.

Exclusion Criteria:

  • Previous allogeneic stem cell transplantation;
  • Patients refusing to sign informed consent for the study;
  • Patients affected by severe cardiomyopathy and respiratory distress/insufficiency;
  • Patients unable to fully understand and accept study protocol for various problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multiparametric ultrasound evaluation
Multiparametric ultrasound evaluation will be applied to all patients who will develop diarrhea above 500 ml per day.
Device: shear wave elastography
Shear wave elastography and CEUS will be used to evaluate the reliability in diagnosing graft versus host disease of the gut after hematopoietic stem cell transplantation
Other Names:
  • contrast enhanced ultrasould (CEUS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity of bed-side multiparametric ultrasound study in gut-GvHD diagnosis will be measured and reported
Time Frame: Onset of gastrointestinal symptoms within 100 days from transplant
Primary endpoint of the study is to evaluate the sensitivity of bed-side multiparametric ultrasound study in the diagnosis of gastrointestinal aGvHD in patients underwent to allogenic transplant
Onset of gastrointestinal symptoms within 100 days from transplant
Specificity of bed-side multiparametric ultrasound study in gut-GvHD diagnosis will be measured and reported
Time Frame: Onset of gastrointestinal symptoms within 100 days from transplant
Primary endpoint of the study is to evaluate the specificity of bed-side multiparametric ultrasound study in the diagnosis of gastrointestinal aGvHD in patients underwent to allogenic transplant
Onset of gastrointestinal symptoms within 100 days from transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elisabetta Metafuni, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4926

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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