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Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL) (LPLB)

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ClinicalTrials.gov Identifier: NCT03296046
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

The main purpose of this study is the description of all French cases of PPBL and the establishment of minimal criteria for the pathology diagnosis and its follow-up.

The secondary objective is the immunologic and genetic characterization of lymphoid cells causing the disease.


Condition or disease Intervention/treatment
Persistent Polyclonal B-Cell Lymphocytosis Biological: Blood test

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL) - Observatory 1990-2012
Actual Study Start Date : November 13, 2012
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015

Group/Cohort Intervention/treatment
PPBL patients Biological: Blood test
30 ml




Primary Outcome Measures :
  1. Relevant medical history [ Time Frame: Baseline ]
  2. Complete blood count [ Time Frame: Baseline ]
  3. Administration of first-line treatment or not [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Lymphocyte phenotype [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA
Venous blood (30 ml) taken during routine care


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PPBL patients in France
Criteria

Inclusion Criteria:

  • PPBL diagnosis established during a previous medical visit

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296046


Locations
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France
group GFHC and intergroup LLC (GCFLL-MW / GOELAMS)
Marseille, France
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03296046    
Other Study ID Numbers: 2011/PSS/LPLB/LESESVE//MS
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphocytosis
Leukocytosis
Leukocyte Disorders
Hematologic Diseases