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

Observational Retrospective Multicenter Study for the Citofluorimetric Analysis of Cerebrospinal Fluid Vs Conventional Method in Patients With Aggressive Non-Hodgkin's Lymphoma Without Leptomeningeal Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00949741

Acronym

CFM

Enrollment

175

Registered

2009-07-30

Start date

2009-07-31

Completion date

2012-10-31

Last updated

2013-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burkitt's Lymphoma, Diffuse Large Cell Lymphoma, Lymphoblastic Lymphoma

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of diagnostic agreement of citofluorimentria flow in the research of lymphoma cells in the cerebrospinal fluid vs cell morphology.	Evaluation at diagnosis	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.

Secondary

Measure	Time frame
Collection of all paper forms	1 year

Countries

Italy

Outcome results