Personalized immunological score to predict severe infections in transplant and immunocompromised patients
Official title: Personalized Immunological Score for the Prediction of Severe Infectious Events in Immunocompromised Patients and Tailored Management (PERISCOPE)
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07379554 · Data updated 2026-11-12
This project will test whether a personalized immunological score can predict serious infections in transplant and other immunocompromised patients and help tailor their care.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Lombardy) |
| Status | Recruiting |
| Started | April 4, 2024 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | January 30, 2026 |
| Trial ID | NCT07379554 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult and pediatric hematopoietic stem cell transplant recipients and solid-organ transplant recipients who can provide written informed consent and attend follow-up at the study center.
✕Probably not a fit
Patients who are not immunocompromised, those without a transplant, those unable to attend the Pavia center, or those who decline consent or follow-up are unlikely to benefit, and the observational design does not guarantee direct clinical benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will collect routine and functional immune-monitoring data, including white blood cell counts, T-lymphocyte subsets, and T-cell functional assays, to develop a personalized immunological score linked to infection outcomes. Adult and pediatric hematopoietic stem cell transplant recipients and solid-organ transplant recipients will be enrolled and followed prospectively at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy. Investigators will correlate immune parameters with occurrence of severe infectious events and explore how the score could inform adjustments in immunosuppression or targeted prophylaxis. No experimental interventions are planned and clinical care will follow standard practice while data are recorded.
Why it matters
Potential benefit: If successful, the score could identify patients at high risk for severe infections so clinicians can target prophylaxis or adjust immunosuppression to reduce complications.
How similar studies have gone: Some centers use immune-monitoring assays such as ImmuKnow with mixed results, so elements of this approach have precedent but a validated personalized composite score remains novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy Recruiting
Study contacts
- Study coordinator: Irene Cassaniti
- Email: i.cassaniti@smatteo.pv.it
- Phone: 0382501089
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.