Diffuse Large Cell LymphomaCFMNCT00949741
Observational Study for the Cytofluorimetric Analysis of Cerebrospinal Fluid in Non-Hodgkin's Lymphoma Patients
An observational study of Diffuse Large Cell Lymphoma and Lymphoblastic Lymphoma, run by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie at 12 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large Cell Lymphoma, Lymphoblastic Lymphoma, Burkitt's Lymphoma
- How many people
- 175 participants
- Where
- 12 sitesItaly
- Study dates
- Jul 2009to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by aggressive non-Hodgkin's lymphoma at diagnosis
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 1. Patients with clinical or strumental evidence of meningeal localization disease.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
ASO SS Antonio e Biagio e Cesare Arrigo
Alessandria, AL, 15100
Centro di riferimento Oncologico Divisione Oncologia A
Aviano, PN, 33081
PO Centro Binaghi Divisione di Ematologia CTMO
Cagliari, CA, 09121
Az. Ospedaliero Universitaria Careggi
Florence, FI, 50134
Ospedale Vito Fazzi Divisione di Ematologia
Lecce, LE, 73100
IRCCS San Raffaele
Milan, MI
Ospedale San Gerardo
Monza, MI, 20052
Ematologia Università del Piemonte Orientalr
Novara, 28100
AO Univ. Policlinico Tor Vergata Divisione di Ematologia
Roma, RM, 00133
Università La Sapienza Policlinico Umberto I
Roma, RM, 00161
SCDO Ematologia 2 AOU San Giovanni Battista
Torino, 10126
Ospedale Cardinale Panico
Tricase, LE, 73039
About this study
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
The purpose of this study is to define if flow cytometry has more sensitivity for detecting neoplastic cells in cerebrospinal fluid versus conventional cytology.
Read the 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.
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of diagnostic agreement of citofluorimentria flow in the research of lymphoma cells in the cerebrospinal fluid vs cell morphology.
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.
Measured: Evaluation at diagnosis
Secondary outcomes (1)
Collection of all paper forms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
- Sponsor type
- University, hospital or other
- Collaborators
- Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
- Responsible party
- Sponsor
- Investigators
- Umberto Vitolo, MD, Principal investigator, SCDO Ematologia AOU San Giovanni Battista Torino Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949741
- Sponsor's protocol ID
- CFM
- Acronym
- CFM
- Status last verified
- Jul 2009
- First submitted
- 29 Jul 2009
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00949741
- Acronym / sponsor ID
- CFM / CFM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle LeucemieUniversity, hospital or other
- Collaborators
- Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
- Study start
- Jul 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by aggressive non-Hodgkin's lymphoma at diagnosis
Key inclusion criteria (9 listed)
- Diagnosis of
- DLCL patients who presented one risk factor for leptomeningeal involvement as:
- Patients with cytologic and flow cytometry on cerebrospinal fluid at diagnosis.
Key exclusion criteria (1 listed)
- 1. Patients with clinical or strumental evidence of meningeal localization disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Collection of all paper forms
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umberto Vitolo, MD principal investigator
SCDO Ematologia AOU San Giovanni Battista Torino Italy
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large Cell Lymphoma and Lymphoblastic Lymphoma, run by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.