NCT01478269

Brief Summary

This study is a retrospective analysis of an homogeneous population of patients with aggressive B-cell lymphoma and treated upfront with R-CHOP or R-CHOP like regimens to reassess the prognostic factors and hopefully to identify more accurate prognostic subgroups with a clinical and therapeutical relevance.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,927

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Geographic Reach
2 countries

39 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

May 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

2 years

First QC Date

October 12, 2011

Last Update Submit

November 22, 2011

Conditions

Keywords

Aggressive B-cell lymphomaR-CHOP

Study Arms (1)

Cases of aggressive B-cell lymphoma

Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy

Eligibility Criteria

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

Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy

You may qualify if:

  • Histologically confirmed newly diagnosed aggressive B-cell lymphoma according to the current World Health Organisation Classification, from 2001 to 2007.
  • Any stage of disease.
  • Treatment with R-CHOP or R-CHOP like regimens (+/- transplant).
  • Age at least 18 years.
  • Availability of tissue biopsy at diagnosis for a possible centralized revision.
  • Availability of data on clinical involvement, laboratory, treatment and follow up.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Hemocentro-Unicamp

Campinas, Brazil

Location

Centro Medico

Santa Isabel, Brazil

Location

Centro Paulista de Oncologia

São Paulo, Brazil

Location

Santa Casa Medical School

São Paulo, Brazil

Location

Clinica Ematologica Policlinico Carreggi

Florence, Firenze, 50134, Italy

Location

Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori

Milan, Milano, Italy

Location

A.O.SS. Biagio, Antonio e Cesare Arrigo

Alessandria, Italy

Location

Centro di riferimento Oncologico Oncologia Medica A

Aviano (Pordenone), Italy

Location

USC Ematologia e Trapianto di Midollo Osseo Ospedali Riuniti di Bergamo

Bergamo, Italy

Location

Presidio Ospedaliero A.Perrino - Divisione di Ematologia

Brindisi, Italy

Location

U.O. di Oncologia Ospedale di Circolo di Busto Arsizio

Busto Arsizio, Italy

Location

Ospedale Civile

Camposanpiero (PD), Italy

Location

A.O.Pugliese Ciaccio Diviisone di Ematologia

Catanzaro, Italy

Location

Presidio Ospedaliero Annunziata U.O.C. di Ematologia

Cosenza, Italy

Location

Ematologia 1 Ospedale S. Martino

Genova, 16132, Italy

Location

Oncologia Medica B e C IST Genova

Genova, Italy

Location

Ospedale Felettino

La Spezia, Italy

Location

Ospedale Madonna delle grazie U.O. Ematologia

Matera, Italy

Location

A O Papardo

Messina, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Gaetano Martino

Messina, Italy

Location

Oncologia Medica 3 Istituto Nazionale dei Tumori di Milano

Milan, Italy

Location

Osp. San Carlo Borromeo Divisione di Oncologia Medica

Milan, Italy

Location

Ospedale Maggiore IRCCS-Dipartimento di Ematologia

Milan, Italy

Location

Centro Oncologico Modenese

Modena, Italy

Location

A.O. Maggiore della Carità S.C.D.U. Ematologia

Novara, Italy

Location

A.O. di Padova Divisione di Oncologia Medica

Padua, Italy

Location

Casa di cura La Maddalena Unita' di Ematologia

Palermo, Italy

Location

Div. di Ematologia e TMO AOU Policlinico Giaccone di Palermo

Palermo, Italy

Location

A O Universitaria di Parma

Parma, Italy

Location

Ospedale Civile G.da Saliceto - UOA Ematologia

Piacenza, Italy

Location

Azienda Ospedaliero Universitaria Pisana U.O. Ematologia

Pisa, Italy

Location

AO Bianchi Melacrino Morelli UO Ematologia

Reggio Calabria, Italy

Location

AO Arcispedale S.Maria Nuova Ematologia

Reggio Emilia, Italy

Location

Ospedale Oncologico regionale CROB

Rionero in Vulture (PZ), Italy

Location

Dipartimento di biotecnologie cellulari ed ematologia Ospedale Umberto I - La Sapienza

Roma, Italy

Location

Policlinico A. Gemelli Università Cattolica del Sacro Cuore

Roma, Italy

Location

Clinica Humanitas

Rozzano (MI), Italy

Location

A.O.San Giovanni Battista

Torino, Italy

Location

U.O. Oncologia Azienda ULSS7 P.O. di Vittorio Veneto

Vittorio Veneto, Italy

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Massimo Federico, MD

    Oncologia II Azienda Ospedaliera Universitaria di Modena

    STUDY DIRECTOR
  • Stefano Luminari, MD

    Oncologia II Azienda Ospedaliera Universitaria di Modena

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 12, 2011

First Posted

November 23, 2011

Study Start

May 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations