Personalized Immunological Score for the Prediction of Severe Infectious Events in Immunocompromised Patients and Tailored Management (PERISCOPE) (PERISCOPE)

January 23, 2026 updated by: Irene Cassaniti, Fondazione IRCCS Policlinico San Matteo di Pavia

Transplants have improved clinical conditions for many patients with haematological diseases and end-stage organ diseases. However, immunosuppressive therapies that are necessary for avoiding organ rejection have a crucial impact in the occurrence of opportunistic infections. Despite the development of effective antimicrobial agents, infectious diseases are still related to mortality and morbidity in immunocompromised patients. Immune function assays can be adopted for monitoring T-cell function and eventually modify immunosuppression. Given the inverse relationship between cellular immune reconstitution and risk of infection, many transplant centers prospectively monitor immune recovery post-transplant. Some basic methods are useful, including white blood cells and T-lymphocyte subsets count. Given the complexity of immune responses required to resolve infections, functional assays are necessary and the only available FDA-approved one is Cyclex-Immuknow. Viral infections are common in patients with T-cell deficiencies and are of particular concern in those receiving high dose steroids. Opportunistic infections are common during the period of highest immunosuppression while community acquired infections, including fungal and respiratory viruses infections, have to be considered in the long-term period. Reduced CD4+ and CD8+ T-lymphocyte counts correlate with risk of opportunistic infection, including human cytomegalovirus (HCMV). Moreover, a decrease in human Rhinovirus (HRV) load in pediatric hematopoietic stem cell transplant recipients (HSCTRs) was associated with a significant increase in T-CD4+, T-CD8+ and NK lymphocytes, suggesting that cellular immunity have a crucial role in viral clearance and infectious control. A recent study showed that poor NK-cell cytotoxic activity is associated with increased risk for severe infections in kidney-graft recipients, suggesting that assessment of NK-cell function may be used as a predictor of infection in immunocompromised patients. Moreover, it has been recently reported that NKG2C genotype influences receptor function and NKG2C+ NK cell number in HCMV seropositive subjects. In detail, NKG2C genotype is significantly associated with HCMV viremia frequency and related disease after lung transplant and with symptomatic CMV infection after kidney transplant. Beside the use of non-specific immunological markers, the lack of standardized quantitative measures of protective immune functions specific for different opportunistic pathogens represents a challenge for clinicians. Overall, a comprehensive approach based on the use of combined non-specific and pathogen-specific immune assays may help in the definition of a composite immune risk profile of immunocompromised patients. The ultimate goal of this research is the definition of algorithms of infectious risk in immunocompromised patients, leading to a more adherent administration of immunosuppressive and antimicrobial therapies as well as to a personalized strategy of patients' management. Moreover, the design of new immunological assays that can be standardized and used in the clinical practice will be obtained.

Currently, even if an immunological monitoring of immunocompromised patients is recommended, no standardized assays and protocols are available, especially for the use of antigen-specific or functional assays. The introduction of diagnostics algorithms will be useful for the stratification of patients at high risk of infections that will be monitored more frequently in order to prevent severe infections. Similarly, the administration of immunosuppressive drugs or ad hoc therapies might be tailored according to the risk of infections or complications. Objective is to identify a composite immune score measured either before or one month after transplant/chemotherapy able to define the risk for clinically significant infections (e.g. infections requiring antimicrobial therapy or hospitalization) during the following three months.

Primary endpoint:

To identify a composite immune score measured either before or one month after transplant/chemotherapy able to define the risk for clinically significant infections (e.g. infections requiring antimicrobial therapy or hospitalization) during the following three months.

Secondary endpoints:

  • To evaluate the prognostic effect of the immunological score measured before or at first month after transplant/chemotherapy on the risk of severe infection during the following 6-12 months
  • To compare the role of the composite immunological score with specific assays against each pathogen.
  • To develop simple and rapid assays using whole blood to evaluate specific pathogen responses

Study Overview

Status

Status

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

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.

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.
Observational

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.
150

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult hematopoietic stem cell transplant recipients (a-HSCTR)

  • pediatric hematopoietic stem cell transplant recipients (p-HSCTR)
  • solid organ transplant recipients (SOTR), including kidney, heart and lung transplanted patients.

Description

Inclusion Criteria:

adult hematopoietic stem cell transplant recipients (a-HSCTR)

  • pediatric hematopoietic stem cell transplant recipients (p-HSCTR)
  • solid organ transplant recipients (SOTR), including kidney, heart and lung transplanted patients.

Written informed consent

Exclusion Criteria:

  • no written informed consent

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Immunocompromised patients

We plan to prospectively enroll 150 immunocompromised patients during the first year of the study, including:

  • adult hematopoietic stem cell transplant recipients (a-HSCTR)
  • pediatric hematopoietic stem cell transplant recipients (p-HSCTR)
  • solid organ transplant recipients (SOTR), including kidney, heart and lung transplanted patients.

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
Immunological score for predicting severe infections
Time Frame: From enrolment to three months of follow up
A composite immune score including overall number of T cells (CD3+CD4+, CD3+CD8+, CD3-CD56+NK cells, CD19+ B cells), Herpesviruses-specific T-cell response (e.g CMV, EBV, HSV1 and 2, VZV) measured before or one month after transplant/chemotherapy will be compared in patients with and without clinically significant infections (e.g. infections requiring antimicrobial therapy or hospitalization) registered during the following three months.
From enrolment to three months of follow up

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 IRCCS Policlinico San Matteo di Pavia

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.
April 4, 2024

Primary Completion (Estimated)

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.
June 1, 2026

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.
June 1, 2026

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).
December 5, 2025

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.
January 23, 2026

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.
January 30, 2026

Study Record Updates

Last Update Posted (Actual)

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.
January 30, 2026

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.
January 23, 2026

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

Additional Relevant MeSH Terms

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.
  • PERISCOPE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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