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

NCT02859623 | Completed

• 1 other identifier: LpDC
• Study Type: observational
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm; Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

• description of the efficacy of treatments for BPDCN

  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 Outcomes (8)

• description of clinical profiles of patients

  from the diagnosis to death or until June 2013, end of data collection

• description of biological profiles of patients

  from the diagnosis to death or until June 2013, end of data collection

• complete remission rate

  from the diagnosis to death or until June 2013, end of data collection

• mean duration of the first remission

  from the diagnosis to death or until June 2013, end of data collection

• survival without events

  from the diagnosis to death or until June 2013, end of data collection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Leukemia; Lymphoma; Neoplasms by Site; Skin Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: August 9, 2016
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Last Updated: August 9, 2016

Record last verified: 2016-07