NCT00949741

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 22, 2013

Status Verified

July 1, 2009

Enrollment Period

2.3 years

First QC Date

July 29, 2009

Last Update Submit

October 21, 2013

Conditions

Diffuse Large Cell LymphomaLymphoblastic LymphomaBurkitt's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Evaluation at diagnosis

Secondary Outcomes (1)

  • Collection of all paper forms

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients affected by aggressive non-Hodgkin's lymphoma at diagnosis

You may qualify if:

  • 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,
  • age-adjusted IPI score with more than 1 extranodal site and LDH \> normal.
  • Patients with cytologic and flow cytometry on cerebrospinal fluid at diagnosis.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

ASO SS Antonio e Biagio e Cesare Arrigo

Alessandria, AL, 15100, Italy

Location

PO Centro Binaghi Divisione di Ematologia CTMO

Cagliari, CA, 09121, Italy

Location

Az. Ospedaliero Universitaria Careggi

Florence, FI, 50134, Italy

Location

Ospedale Vito Fazzi Divisione di Ematologia

Lecce, LE, 73100, Italy

Location

Ospedale Cardinale Panico

Tricase, LE, 73039, Italy

Location

IRCCS San Raffaele

Milan, MI, Italy

Location

Ospedale San Gerardo

Monza, MI, 20052, Italy

Location

Centro di riferimento Oncologico Divisione Oncologia A

Aviano, PN, 33081, Italy

Location

AO Univ. Policlinico Tor Vergata Divisione di Ematologia

Roma, RM, 00133, Italy

Location

Università La Sapienza Policlinico Umberto I

Roma, RM, 00161, Italy

Location

Ematologia Università del Piemonte Orientalr

Novara, 28100, Italy

Location

SCDO Ematologia 2 AOU San Giovanni Battista

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffusePrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Umberto Vitolo, MD

    SCDO Ematologia AOU San Giovanni Battista Torino Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

October 22, 2013

Record last verified: 2009-07

Locations

IT(12)