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

Completed

• Conditions: Lymphoblastic Lymphoma; Burkitt's Lymphoma; Diffuse Large Cell Lymphoma

• Registration Number: NCT00949741
• Lead Sponsor: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

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.

Study Timeline

• Status Verified: 2009-07
• Study Start: 2009-07
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Primary Completion: 2011-10
• Study Completion: 2012-10
• Last Update Submitted: 2013-10-21
• Last Update Posted: 2013-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Collection of all paper forms	1 year

Trial Locations

Locations (12)

ASO SS Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, AL, Italy

Az. Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, FI, Italy

SCDO Ematologia 2 AOU San Giovanni Battista; 🇮🇹 Torino, Italy

Ospedale San Gerardo; 🇮🇹 Monza, MI, Italy

AO Univ. Policlinico Tor Vergata Divisione di Ematologia; 🇮🇹 Roma, RM, Italy

Università La Sapienza Policlinico Umberto I; 🇮🇹 Roma, RM, Italy

Ospedale Cardinale Panico; 🇮🇹 Tricase, LE, Italy

Ematologia Università del Piemonte Orientalr; 🇮🇹 Novara, Italy

PO Centro Binaghi Divisione di Ematologia CTMO; 🇮🇹 Cagliari, CA, Italy

Ospedale Vito Fazzi Divisione di Ematologia; 🇮🇹 Lecce, LE, Italy

IRCCS San Raffaele; 🇮🇹 Milano, MI, Italy

Centro di riferimento Oncologico Divisione Oncologia A; 🇮🇹 Aviano, PN, Italy