Descriptive Study of the Efficacy of Treatments for Blastic Dendritic Cell Neoplasm (BPDCN) (LpDC)

August 4, 2016 updated by: Centre Hospitalier Universitaire de Besançon

Descriptive Study of the Efficacy of Treatments for Blastic Dendritic Cell Neoplasm (BPDCN): a Retrospective Study of Patients Diagnosed in France From 2000 to 2013

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare disease characterized by an aggressive clinical behavior and a poor prognosis. It predominantly affects elderly males with an average age of 67 years at diagnosis and the affected organs are usually the skin, bone marrow, lymph nodes and the central nervous system. Patients with BPDCN have poor outcomes with median overall survival (OS) ranging in the largest series of patients from 8 to 12 months.

Patient care must be defined in this pathology. Despite 40%-90% complete remission (CR) rates after initial chemotherapy, relapses are almost inevitable.

The investigators have developed a national network to collect clinical and biological data of French patients diagnosed with BPDCN.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

86

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study concerns patients diagnosed with blastic plasmacytoid dendritic cell neoplasm (BPDCN) from January 2000 to June 2013.

Description

Inclusion Criteria:

  • Patients diagnosed with blastic plasmacytoid dendritic cell neoplasm (BPDCN) from January 2000 to June 2013 in France.
  • Diagnosis should be established by hematology laboratory of French blood Agency of Bourgogne Franche-Comté and/or by anatomopathological analysis (realized in local centres or by Tony Petrella at Dijon University Hospital) according to phenotypic and anatomopathological criteria published in the literature.

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
description of the efficacy of treatments for BPDCN
Time Frame: from the diagnosis to death or until June 2013, date of end of data collection
Measurement of the overall survival for all patients from the date of diagnostic until death or end of data collection
from the diagnosis to death or until June 2013, date of end of data collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
description of clinical profiles of patients
Time Frame: from the diagnosis to death or until June 2013, end of data collection
presence of cutaneous lesions
from the diagnosis to death or until June 2013, end of data collection
description of biological profiles of patients
Time Frame: from the diagnosis to death or until June 2013, end of data collection
immunophenotyping profile
from the diagnosis to death or until June 2013, end of data collection
complete remission rate
Time Frame: from the diagnosis to death or until June 2013, end of data collection
from the diagnosis to death or until June 2013, end of data collection
mean duration of the first remission
Time Frame: from the diagnosis to death or until June 2013, end of data collection
from the diagnosis to death or until June 2013, end of data collection
survival without events
Time Frame: from the diagnosis to death or until June 2013, end of data collection
from the diagnosis to death or until June 2013, end of data collection
non-responders rate
Time Frame: from the diagnosis to death or until June 2013, end of data collection
from the diagnosis to death or until June 2013, end of data collection
time interval between two treatments
Time Frame: from the diagnosis to death or until June 2013, end of data collection
from the diagnosis to death or until June 2013, end of data collection
mortality without relapse
Time Frame: from the diagnosis to death or until June 2013, end of data collection
from the diagnosis to death or until June 2013, end of data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LpDC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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