NCT03296046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

3.1 years

First QC Date

September 22, 2017

Last Update Submit

September 27, 2017

Conditions

Persistent Polyclonal B-Cell Lymphocytosis

Outcome Measures

Primary Outcomes (3)

  • Relevant medical history

    Baseline

  • Complete blood count

    Baseline

  • Administration of first-line treatment or not

    Baseline

Secondary Outcomes (1)

  • Lymphocyte phenotype

    Baseline

Study Arms (1)

PPBL patients

Biological: Blood test

Interventions

Blood testBIOLOGICAL

30 ml

PPBL patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PPBL patients in France

You may qualify if:

  • PPBL diagnosis established during a previous medical visit

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

group GFHC and intergroup LLC (GCFLL-MW / GOELAMS)

Marseille, France

Location

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood (30 ml) taken during routine care

MeSH Terms

Conditions

Persistent Polyclonal B-Cell Lymphocytosis

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2017

First Posted

September 28, 2017

Study Start

November 13, 2012

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

September 28, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)