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

Lymphoblastic Lymphoma Clinical Trial

— CFM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949741
• Other study ID #: CFM
• Status: Completed
• Phase: N/A
• First received: July 29, 2009
• Last updated: October 21, 2013
• Start date: July 2009
• Est. completion date: October 2012

Study information

• Verified date: July 2009
• Source: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Burkitt's Lymphoma
• Diffuse Large Cell Lymphoma
• Lymphoblastic Lymphoma
• Lymphoma
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin

Locations

Country	Name	City	State
Italy	ASO SS Antonio e Biagio e Cesare Arrigo	Alessandria	AL
Italy	Centro di riferimento Oncologico Divisione Oncologia A	Aviano	PN
Italy	PO Centro Binaghi Divisione di Ematologia CTMO	Cagliari	CA
Italy	Az. Ospedaliero Universitaria Careggi	Firenze	FI
Italy	Ospedale Vito Fazzi Divisione di Ematologia	Lecce	LE
Italy	IRCCS San Raffaele	Milano	MI
Italy	Ospedale San Gerardo	Monza	MI
Italy	Ematologia Università del Piemonte Orientalr	Novara
Italy	AO Univ. Policlinico Tor Vergata Divisione di Ematologia	Roma	RM
Italy	Università La Sapienza Policlinico Umberto I	Roma	RM
Italy	SCDO Ematologia 2 AOU San Giovanni Battista	Torino
Italy	Ospedale Cardinale Panico	Tricase	LE

Sponsors (2)

Lead Sponsor	Collaborator
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie	Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Evaluation at diagnosis	No
Secondary	Collection of all paper forms		1 year	No