ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00949741
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : October 22, 2013
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

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.

Condition or disease
Diffuse Large Cell Lymphoma Lymphoblastic Lymphoma Burkitt's Lymphoma

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
Actual Enrollment : 175 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2012





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Collection of all paper forms [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
AO Univ. Policlinico Tor Vergata Divisione di Ematologia
Roma, RM, Italy, 00133
Università La Sapienza Policlinico Umberto I
Roma, RM, Italy, 00161
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

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
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: July 2009

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