Observational Study for the Cytofluorimetric Analysis of Cerebrospinal Fluid in Non-Hodgkin's Lymphoma Patients (CFM)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
Collaborator:
Epidemiologia e prevenzione Oncologica (CPO)in Piemonte
Information provided by:
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
ClinicalTrials.gov Identifier:
NCT00949741
First received: July 29, 2009
Last updated: July 30, 2009
Last verified: July 2009
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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:
Secondary Outcome Measures:
- Collection of all paper forms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2011 |
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:
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:
1. Patients with clinical or strumental evidence of meningeal localization disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949741
Contacts
| Contact: Lina LD De Masi, Datamanager | 011/6335611 | pdemasi@molinette.piemonte.it |
| Contact: Giulia GB Benevolo, co-investig | 011/6335937 |
Locations
| Italy | |
| ASO SS Antonio e Biagio e Cesare Arrigo | Recruiting |
| Alessandria, AL, Italy, 15100 | |
| Contact: Alessandro Levis, MD 0131/206129 alevis@ospedale.molinette.piemonte.it | |
| PO Centro Binaghi Divisione di Ematologia CTMO | Recruiting |
| Cagliari, CA, Italy, 09121 | |
| Contact: Marcella Arras, MD | |
| Az. Ospedaliero Universitaria Careggi | Recruiting |
| Firenze, FI, Italy, 50134 | |
| Contact: Luigi Rigacci, MD .055/7947958 Emopatologia@dfc.unifi.it | |
| Ospedale Vito Fazzi Divisione di Ematologia | Recruiting |
| Lecce, LE, Italy, 73100 | |
| Contact: Nicola Di Renzo, MD 0832/661111 nicola.direnzo@fastwebnet.it | |
| Ospedale Cardinale Panico | Recruiting |
| Tricase, LE, Italy, 73039 | |
| Contact: Vincenzo Pavone, MD 0833/773460 salentoematologia@piafondazionepanico.it | |
| IRCCS San Raffaele | Recruiting |
| Milano, MI, Italy | |
| Contact: Andres Ferreri, MD | |
| Ospedale San Gerardo | Recruiting |
| Monza, MI, Italy, 20052 | |
| Contact: Enrico Pogliani, MD 039/2333437 enrico.pogliani@unimib.it | |
| Centro di riferimento Oncologico Divisione Oncologia A | Recruiting |
| Aviano, PN, Italy, 33081 | |
| Contact: Michele Spina, MD 0434/659730 mspina@cro.it | |
| Università La Sapienza Policlinico Umberto I | Recruiting |
| Roma, RM, Italy, 00161 | |
| Contact: Maurizio Martelli, MD 06/857951 martelli@bce.uniroma1.it | |
| AO Univ. Policlinico Tor Vergata Divisione di Ematologia | Recruiting |
| Roma, RM, Italy, 00133 | |
| Contact: Maria Cantonetti, MD | |
| SCDO Ematologia 2 AOU San Giovanni Battista | Recruiting |
| Torino, Italy, 10126 | |
| Contact: Umberto Vitolo, MD 011/6335934 uvitolo@molinette.piemonte.it | |
| Contact: Giulia Benevolo, MD 011/6334553 rivgio@libero.it | |
Sponsors and Collaborators
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
Epidemiologia e prevenzione Oncologica (CPO)in Piemonte
Investigators
| Principal Investigator: | Umberto Vitolo, MD | SCDO Ematologia AOU San Giovanni Battista Torino Italy |
More Information
No publications provided
| Responsible Party: | Dr. Umberto Vitolo, Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie Onlus |
| ClinicalTrials.gov Identifier: | NCT00949741 History of Changes |
| Other Study ID Numbers: | CFM |
| Study First Received: | July 29, 2009 |
| Last Updated: | July 30, 2009 |
| 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 May 19, 2013