Clinical trial NCT00949741: Observational Study for the Cytofluorimetric Analysis of Cerebrospinal Fluid in Non-Hodgkin's Lymphoma Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large Cell Lymphoma
Lymphoblastic Lymphoma
Burkitt's Lymphoma
Lead sponsor: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
Sponsor class: OTHER
Collaborators: name: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
First posted: 2009-07-30
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by aggressive non-Hodgkin's lymphoma at diagnosis

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.

Eligibility 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.

Primary outcomes:
measure: Evaluation of diagnostic agreement of citofluorimentria flow in the research of lymphoma cells in the cerebrospinal fluid vs cell morphology.
timeFrame: Evaluation at diagnosis
Secondary outcomes:
measure: Collection of all paper forms
timeFrame: 1 year
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: ASO SS Antonio e Biagio e Cesare Arrigo
state: AL
city: Cagliari
country: Italy
facility: PO Centro Binaghi Divisione di Ematologia CTMO
state: CA
city: Firenze
country: Italy
facility: Az. Ospedaliero Universitaria Careggi
state: FI
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi Divisione di Ematologia
state: LE
city: Tricase
country: Italy
facility: Ospedale Cardinale Panico
state: LE
city: Milano
country: Italy
facility: IRCCS San Raffaele
state: MI
city: Monza
country: Italy
facility: Ospedale San Gerardo
state: MI
city: Aviano
country: Italy
facility: Centro di riferimento Oncologico Divisione Oncologia A
state: PN
city: Roma
country: Italy
facility: AO Univ. Policlinico Tor Vergata Divisione di Ematologia
state: RM
city: Roma
country: Italy
facility: Università La Sapienza Policlinico Umberto I
state: RM
city: Novara
country: Italy
facility: Ematologia Università del Piemonte Orientalr
city: Torino
country: Italy
facility: SCDO Ematologia 2 AOU San Giovanni Battista
Study officials:
affiliation: SCDO Ematologia AOU San Giovanni Battista Torino Italy
name: Umberto Vitolo, MD
role: PRINCIPAL_INVESTIGATOR
References: