Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585124
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Flow Cytometry for the Study of T-Cell Populations in Hemophagocytic Lymphohistiocytosis Associated With Lymphomas
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Observational Study on the Application of Flow Cytometry for the Study of T-Cell Populations in Lymphoma-associated Hemophagocytic Lymphohistiocytosis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LA-HLH
Brief 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
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
Detailed Description:
Hemophagocytic lymphohistiocytosis HLH is a rare and severe syndrome characterized by excessive immune system activation and dysregulation This leads to an overproduction of cytokines and activation of the histiocytic-macrophage system potentially resulting in multi-organ failure and death HLH can be classified into primary and secondary forms Secondary HLH is often triggered by infections autoimmune diseases or neoplasms with lymphomas being the most frequent neoplastic triggers
There is limited knowledge about secondary HLH particularly regarding early diagnosis and optimal management This project aims to address this gap by analyzing cytotoxic T-cells and cell expression markers using flow cytometry building on findings from two pediatric studies
Aggressive onset lymphomas may induce a systemic hyperinflammatory state complicating the diagnosis of HLH especially in the presence of concurrent bacterial or viral infections Given the rarity of HLH and its poor prognosis if not promptly diagnosed further research is crucial especially in lymphoma-associated cases
This study aims to apply T-cell activation profiling previously demonstrated in pediatric populations to patients with aggressive Non-Hodgkins Lymphoma and Hodgkins Lymphoma to identify HLH-associated cases at onset
The study aims to include 150 patients diagnosed with aggressive lymphoma within a one-year period A peripheral blood sample collected alongside routine blood chemistry tests at diagnosis will be used for the flow cytometric study of the T-lymphocyte activation profile Data pertaining to disease characteristics will be gathered to calculate diagnostic scores for HLH including the H-score HLH-2004 score and OHI score The flow cytometry results will then be compared with these score parameters to assess their correlation with the diagnosis of lymphoma-associated HLH LA-HLH
There is limited knowledge about secondary HLH particularly regarding early diagnosis and optimal management This project aims to address this gap by analyzing cytotoxic T-cells and cell expression markers using flow cytometry building on findings from two pediatric studies
Aggressive onset lymphomas may induce a systemic hyperinflammatory state complicating the diagnosis of HLH especially in the presence of concurrent bacterial or viral infections Given the rarity of HLH and its poor prognosis if not promptly diagnosed further research is crucial especially in lymphoma-associated cases
This study aims to apply T-cell activation profiling previously demonstrated in pediatric populations to patients with aggressive Non-Hodgkins Lymphoma and Hodgkins Lymphoma to identify HLH-associated cases at onset
The study aims to include 150 patients diagnosed with aggressive lymphoma within a one-year period A peripheral blood sample collected alongside routine blood chemistry tests at diagnosis will be used for the flow cytometric study of the T-lymphocyte activation profile Data pertaining to disease characteristics will be gathered to calculate diagnostic scores for HLH including the H-score HLH-2004 score and OHI score The flow cytometry results will then be compared with these score parameters to assess their correlation with the diagnosis of lymphoma-associated HLH LA-HLH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None