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NCT Number: NCT00949741

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

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

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Key information

Conditions

Diffuse Large Cell Lymphoma Burkitt Lymphoma Burkitt's Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoblastic Lymphoma Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Tumor Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASO SS Antonio e Biagio e Cesare Arrigo, Alessandria, AL, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of
  • Diffuse large cell lymphoma HIV positive,
  • Lymphoblastic lymphoma,
  • Burkitt's lymphoma,
  • Mantle cell lymphoma blastoid type.
  • 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.
  • Patients with cytologic and flow cytometry on cerebrospinal fluid at diagnosis.

Exclusion criteria

  • Patients with clinical or strumental evidence of meningeal localization disease.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Collection of all paper forms

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

Other

Collaborators

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

Registry information

Official study 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

Acronym: CFM

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jul 30, 2009
Registry last updated
Oct 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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