Observational Study for the Cytofluorimetric Analysis of Cerebrospinal Fluid in Non-Hodgkin's Lymphoma Patients

Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie175 enrolled

Overview

The purpose of this study is to define if flow cytometry has more sensitivity for detecting neoplastic cells in cerebrospinal fluid versus conventional cytology.

Aggressive B-cell non-Hodgkin's lymphoma (B-NHL), Lymphoblastic Lymphoma and Burkitt's Lymphoma are at high risk of CNS relapse. For this reason is recommended a prophylaxis therapy. This suggests that negative leptomeningeal localization patients at diagnosis are really positive and that would be a very high risk of CNS relapse subtype patients. It's very important detecting neoplastic cells in cerebrospinal fluid as soon as possible. This study will evaluate only patients that have been flow cytometry and cytology at diagnosis.

Study Type

OBSERVATIONAL

Enrollment

175

Conditions

Diffuse Large Cell Lymphoma Lymphoblastic Lymphoma Burkitt's Lymphoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of * Diffuse large cell lymphoma HIV positive, * Lymphoblastic lymphoma, * Burkitt's lymphoma, * Mantle cell lymphoma blastoid type. 2. DLCL patients who presented one risk factor for leptomeningeal involvement as: * testis, bone marrow, orbit, palate, paranasal cavity or peridural disease localization, * 2-3 age-adjusted IPI score with more than 1 extranodal site and LDH \> normal. 3. Patients with cytologic and flow cytometry on cerebrospinal fluid at diagnosis. Exclusion Criteria: 1\. Patients with clinical or strumental evidence of meningeal localization disease.

Locations (12)

ASO SS Antonio e Biagio e Cesare Arrigo

Alessandria, AL, Italy

PO Centro Binaghi Divisione di Ematologia CTMO

Cagliari, CA, Italy

Az. Ospedaliero Universitaria Careggi

Florence, FI, Italy

Outcomes

Primary Outcomes

Evaluation of diagnostic agreement of citofluorimentria flow in the research of lymphoma cells in the cerebrospinal fluid vs cell morphology.

Evaluation of diagnostic agreement of citofluorimentria flow in the research of lymphoma cells in the cerebrospinal fluid vs cell morphology. The second test will be performed independently and without the cytologist is aware of the outcome of the analysis by flow cytometry.

Time frame: Evaluation at diagnosis

Secondary Outcomes

Collection of all paper forms

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.