RecruitingNCT06585124

Flow Cytometry for the Study of T-Cell Populations in Hemophagocytic Lymphohistiocytosis Associated With Lymphomas

Observational Study on the Application of Flow Cytometry for the Study of T-Cell Populations in Lymphoma-associated Hemophagocytic Lymphohistiocytosis


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

150 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this study is to explore the associations between T cell activation and the occurrence of hemophagocytic lymphohistiocytosis (HLH) in patients with newly diagnosed lymphomas. The specific aims are: Prediction of Lymphoma-Associated HLH (LA-HLH): Compare flow cytometric T cell activation markers with the H-score to predict LA-HLH. Identification of new markers for predicting HLH in patients with aggressive lymphoma. Description of the incidence rate of LA-HLH. Assessment of the outcomes of LA-HLH identified by flow cytometric analysis or the H-score. This prospective, single-center observational study will include 150 patients newly diagnosed with aggressive lymphoma within one year. Peripheral blood samples will be taken at diagnosis alongside routine blood chemistry tests for flow cytometric analysis of the T-lymphocyte activation profile. Data on disease characteristics will be collected to calculate the H-score, HLH-2004 score, and OHI score for diagnosing HLH. The flow cytometry results will be compared with these scores to evaluate their effectiveness in diagnosing LA-HLH.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is analyzing immune cells (specifically T-cells) in the blood of patients with aggressive lymphoma who develop a life-threatening complication called hemophagocytic lymphohistiocytosis (HLH) — a condition where the immune system becomes dangerously overactivated. Researchers want to better understand why this happens in some lymphoma patients. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with an aggressive type of lymphoma, such as Hodgkin lymphoma, diffuse large B-cell lymphoma, or certain T-cell lymphomas - You have developed or are suspected of developing HLH (immune system overactivation) in the context of your lymphoma **You may NOT be eligible if...** - You are under 18 years old - You have a different type of lymphoma not listed in the study criteria - You are unable or unwilling to give informed consent - You do not have a diagnosis of aggressive lymphoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTFlow Cytometry

Study of t cell population in flow cytometry


Locations(1)

Stefan Hohaus

Rome, Lazio, Italy

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NCT06585124


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