Actively Recruiting

Age: 18Years +
All Genders
NCT06585124

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-09-05

150

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Diagnosis at onset of aggressive lymphoma including Hodgkin lymphoma
  • Diagnosis of transformed B cell lymphomas
  • Diagnosis of diffuse large B-cell lymphomas including various subtypes
  • Diagnosis of Burkitt lymphoma
  • Diagnosis of KSHV/HHV8 associated lymphomas
  • Diagnosis of lymphomas associated with immunodeficiency or immune dysregulation
  • Diagnosis of mature T-cell-derived lymphomas including various subtypes
  • Informed consent to use biological materials for the study
Not Eligible

You will not qualify if you...

  • Diagnosis of indolent non-Hodgkin's lymphoma or other lymphoma diagnoses not listed in inclusion
  • Prolonged steroid therapy longer than 15 days or high steroid doses exceeding 1 mg/kg
  • Age 18 years or younger

AI-Screening

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Trial Site Locations

Total: 1 location

1

Stefan Hohaus

Rome, Lazio, Italy, 00168

Actively Recruiting

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Research Team

S

Stefan Hohaus, MD

CONTACT

F

Flaminia Bellisario, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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