Blastic Plasmacytoid Dendritic Cell Neoplasm in Korean Population.

NCT03974971 | Completed

• 1 other identifier: 2019-02-035
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective study , To analyze the clinical features and treatment outcomes in Korean blastic plasmacytoid dendritic cell neoplasm.

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

• Overall Survival Rate

  From the date of diagnosis to the date of death, or from the date of diagnosis to the last follow-up date.

  from the date of the IRB approval until June 30, 2019

Secondary Outcomes (3)

• Therapeutic Response Rate

  from the date of the IRB approval until June 30, 2019

• Disease-free Survival Rate

  from the date of the IRB approval until June 30, 2019

• Number of Factors affecting overall survival

  from the date of the IRB approval until June 30, 2019

Study Arms (1)

BPDCN diagnosis group

By review medical records Enroll patients diagnosed with BPDCN from January 1, 2000 to October 31, 2018

Eligibility Criteria

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

Study Population

This study is a retrospective study, in which patients with patients diagnosed with SCC tumors can participate, and patients who meet the selection criteria will be eligible. The purpose of this study is explorative and descriptive, and it is impossible to calculate the statistical background. Therefore, it is estimated that more than 40 patients are diagnosed with the disease in Korea so far.

You may qualify if:

• Patients ≥ 18 years
• Pathologically confirmed diagnosis by tissue or bone marrow at each center with
• Blastic plasmacytoid dendritic cell neoplasm
• Blastic NK-cell lymphoma
• Agranular CD4+ natural killer cell leukaemia
• Blastic natural killer leukaemia/lymphoma
• Agranular CD4+CD56+ haematodermic neoplasm/tumour
• Antigen expression of CD4 and/or CD56 coupled with at least one plasmacytoid dendritic cell-associated antigen among CD123, TCL1, CD2AP and BDCA2/CD303

You may not qualify if:

• Acute myeloid leukemia
• Acute lymphoblastic leukemia
• Mixed phenotype acute leukemia
• Any type of B- or T-/NK/T-cell lymphomas
• Expression of lineage-specific markers for B cells (CD20, CD79a) T cells (CD3) Myeloid cells (myeloperoxidase) Monocytes (CD11c, CD163, lysozyme). CD34

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, Gang Nam, 676, South Korea

Location

MeSH Terms

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm

Condition Hierarchy (Ancestors)

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

Study Officials

• Seokjin Kim, M.D., PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 5, 2019
• Study Start: April 30, 2019
• Primary Completion: June 30, 2019
• Study Completion: February 29, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)