Blastic Plasmacytoid Dendritic Cell NeoplasmLpDCNCT02859623
Descriptive Study of the Efficacy of Treatments for Blastic Dendritic Cell Neoplasm (BPDCN)
An observational study of Blastic Plasmacytoid Dendritic Cell Neoplasm and Hematological Malignancies, run by Centre Hospitalier Universitaire de Besancon.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blastic Plasmacytoid Dendritic Cell Neoplasm, Hematological Malignancies
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study concerns patients diagnosed with blastic plasmacytoid dendritic cell neoplasm (BPDCN) from January 2000 to June 2013.
Who may be able to join
- 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.
Who cannot join
- No exclusion criteria
About this study
Official title: 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.
- Medical subject headings
- Blastic Plasmacytoid Dendritic Cell Neoplasm, Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from the diagnosis to death or until June 2013, date of end of data collection
Secondary outcomes (8)
description of clinical profiles of patients
presence of cutaneous lesions
Measured: from the diagnosis to death or until June 2013, end of data collection
description of biological profiles of patients
immunophenotyping profile
Measured: from the diagnosis to death or until June 2013, end of data collection
complete remission rate
Measured: from the diagnosis to death or until June 2013, end of data collection
mean duration of the first remission
Measured: from the diagnosis to death or until June 2013, end of data collection
survival without events
Measured: from the diagnosis to death or until June 2013, end of data collection
non-responders rate
Measured: from the diagnosis to death or until June 2013, end of data collection
time interval between two treatments
Measured: from the diagnosis to death or until June 2013, end of data collection
mortality without relapse
Measured: from the diagnosis to death or until June 2013, end of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blastic Plasmacytoid Dendritic Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859623
- Sponsor's protocol ID
- LpDC
- Acronym
- LpDC
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02859623
- Acronym / sponsor ID
- LpDC / LpDC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study concerns patients diagnosed with blastic plasmacytoid dendritic cell neoplasm (BPDCN) from January 2000 to June 2013.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
description of clinical profiles of patients
Time frame: 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
complete remission rate
Time frame: 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
survival without events
Time frame: 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
time interval between two treatments
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Blastic Plasmacytoid Dendritic Cell Neoplasm and Hematological Malignancies, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.