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

October 21, 2013 updated by: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy, 28100
        • Ematologia Università del Piemonte Orientalr
      • Torino, Italy, 10126
        • SCDO Ematologia 2 AOU San Giovanni Battista
    • AL
      • Alessandria, AL, Italy, 15100
        • ASO SS Antonio e Biagio e Cesare Arrigo
    • CA
      • Cagliari, CA, Italy, 09121
        • PO Centro Binaghi Divisione di Ematologia CTMO
    • FI
      • Firenze, FI, Italy, 50134
        • Az. Ospedaliero Universitaria Careggi
    • LE
      • Lecce, LE, Italy, 73100
        • Ospedale Vito Fazzi Divisione di Ematologia
      • Tricase, LE, Italy, 73039
        • Ospedale Cardinale Panico
    • MI
      • Milano, MI, Italy
        • IRCCS San Raffaele
      • Monza, MI, Italy, 20052
        • Ospedale San Gerardo
    • PN
      • Aviano, PN, Italy, 33081
        • Centro di riferimento Oncologico Divisione Oncologia A
    • RM
      • Roma, RM, Italy, 00133
        • AO Univ. Policlinico Tor Vergata Divisione di Ematologia
      • Roma, RM, Italy, 00161
        • Università La Sapienza Policlinico Umberto I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients affected by aggressive non-Hodgkin's lymphoma at diagnosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Collection of all paper forms
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

Collaborators

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

Investigators

  • Principal Investigator: Umberto Vitolo, MD, SCDO Ematologia AOU San Giovanni Battista Torino Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (Estimate)

July 30, 2009

Study Record Updates

Last Update Posted (Estimate)

October 22, 2013

Last Update Submitted That Met QC Criteria

October 21, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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