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

NCT ID: NCT00949741

Last Updated: 2013-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Diffuse Large Cell Lymphoma Lymphoblastic Lymphoma Burkitt's Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

OTHER

Sponsor Role collaborator

Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Umberto Vitolo, MD

Role: PRINCIPAL_INVESTIGATOR

SCDO Ematologia AOU San Giovanni Battista Torino Italy

Locations

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ASO SS Antonio e Biagio e Cesare Arrigo

Alessandria, AL, Italy

Site Status

PO Centro Binaghi Divisione di Ematologia CTMO

Cagliari, CA, Italy

Site Status

Az. Ospedaliero Universitaria Careggi

Florence, FI, Italy

Site Status

Ospedale Vito Fazzi Divisione di Ematologia

Lecce, LE, Italy

Site Status

Ospedale Cardinale Panico

Tricase, LE, Italy

Site Status

IRCCS San Raffaele

Milan, MI, Italy

Site Status

Ospedale San Gerardo

Monza, MI, Italy

Site Status

Centro di riferimento Oncologico Divisione Oncologia A

Aviano, PN, Italy

Site Status

AO Univ. Policlinico Tor Vergata Divisione di Ematologia

Roma, RM, Italy

Site Status

Università La Sapienza Policlinico Umberto I

Roma, RM, Italy

Site Status

Ematologia Università del Piemonte Orientalr

Novara, , Italy

Site Status

SCDO Ematologia 2 AOU San Giovanni Battista

Torino, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CFM

Identifier Type: -

Identifier Source: org_study_id