Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry
NCT ID: NCT05430971
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2022-07-01
2032-07-31
Brief Summary
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Detailed Description
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The final diagnosis of BPDCN relies on a compatible immunophenotype. The triple positive CD4+CD56+CD123+ phenotype associated with negativity for lineage-specific markers is a minimum requirement for defining BPDCN. The highly specific marker BDCA2/CD303, as well as other plasmacytoid dendritic cell-associated antigens (e.g. TCL1 and CD2AP), might be of great support to exclude potential mimickers of BPDCN (acute myeloid and monocytic leukemias, precursor lymphoblastic T-cell leukemia/lymphomas and T- and NK/T cell lymphomas.
At present, there is no consensus on the optimal treatment of BPDCN. The majority of patients receive multi-agent chemotherapy with AML or ALL treatment regimens, while a few patients undergo allogeneic haematopoietic stem cell transplantation (HSCT). In recent years, different novel and innovative therapies are in development to target surface molecules in BPDCN. The patients are still in need of better treatments and the optimal therapy of disease remains to be determined.
This is a multicenter, international prospective and retrospective registry with the aim of collecting data of patients with a diagnosis of BPDCN globally.
Patients will be recruited directly by the national study groups / participating centers.
Participating centers will collect and verify informed consent of all prospective patients enrolled at their center.
The following data will be collected through questionnaires:
1. Patient characteristics
2. BPDCN characteristics
3. Treatment details
4. Outcomes
5. Cause of death
6. End of data collection
Quality control and data management will be conducted by the Immune Oncology Research Institute.
Conditions
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Study Design
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CASE_ONLY
OTHER
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent form for prospective patients
Exclusion Criteria
ALL
No
Sponsors
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Immune Oncology Research Institute
OTHER
Responsible Party
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Principal Investigators
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Astghik Voskanyan, MD
Role: PRINCIPAL_INVESTIGATOR
Immune Oncology Research Institute, Yerevan, Armenia
Gevorg Tamamyan, MD, PhD, DSc
Role: STUDY_DIRECTOR
Immune Oncology Research Institute, Yerevan, Armenia
Locations
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Sylvester Comprehensive Cancer Center, University of Miami
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Seattle Children's Cancer and Blood Disorders Center
Seattle, Washington, United States
Hematology Center named after prof. R. Yeolyan
Yerevan, Yerevan, Armenia
University of Calgary
Calgary, Alberta, Canada
Children's Hospital of Eastern Ontario, University of Ottawa
Ottawa, Ontario, Canada
Cyprus Society of Haematology
Nicosia, , Cyprus
Oncology Center, Mansoura University Faculty of Medicine
Al Mansurah, , Egypt
M. Iashvili Children's Central Hospital
Tbilisi, , Georgia
Department of Medical Oncology, Dr. B.R.A Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
New Delhi, , India
Pediatric Hematology Oncology, Children's Welfare Teaching Hospital, Medical City, College of Medicine, University of Baghdad
Baghdad, , Iraq
University of Perugia - Azienda Ospedaliera Perugia
Perugia, , Italy
Department of Biomedicine and Prevention, University of Rome Tor Vergata
Roma, , Italy
Department of hematology, Kuwait Cancer Control Center
Kuwait City, , Kuwait
Fundeni Clinical Institute, Department of Acute Leukemia
Bucharest, , Romania
China Medical University Children's Hospital
Taichung, , Taiwan
Turkish Pediatric Cancer Registry
Ankara, , Turkey (Türkiye)
Istanbul University, Oncology Institute
Istanbul, , Turkey (Türkiye)
University of Health Sciences, Umraniye Research and Education Hospital, Pediatric Hematology and Oncology Department, Pediatric Bone Marrow Transplantation Unit
Istanbul, , Turkey (Türkiye)
Broomfield Hospital, Haematology Mid and South Essex University Hospitals Group
Chelmsford, Essex, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Shushan Hovsepyan, MD
Role: backup
Nerses Ghahramanyan, MD
Role: backup
Sameer Bakhshi, MBBS, MD, DM
Role: primary
Ahmad Alhuraiji, MD, MRCP(UK)
Role: primary
Maria Camelia Stancioaica, MD
Role: primary
Daniel Coriu, MD, PhD
Role: backup
Ching-Tien Peng, MD
Role: backup
Other Identifiers
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IMMONC0002
Identifier Type: -
Identifier Source: org_study_id
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