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

This study has been completed.
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by (Responsible Party):
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
ClinicalTrials.gov Identifier:
NCT00949741
First received: July 29, 2009
Last updated: October 21, 2013
Last verified: July 2009
  Purpose

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


Condition
Diffuse Large Cell Lymphoma
Lymphoblastic Lymphoma
Burkitt's Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Collection of all paper forms [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: July 2009
Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949741

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

No publications provided

Responsible Party: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
ClinicalTrials.gov Identifier: NCT00949741     History of Changes
Other Study ID Numbers: CFM
Study First Received: July 29, 2009
Last Updated: October 21, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Burkitt Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neoplasms by Histologic Type
Neoplasms
Lymphoma, B-Cell
Neoplasms, Experimental
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia

ClinicalTrials.gov processed this record on August 28, 2014