Persistent Polyclonal B-Cell LymphocytosisLPLBNCT03296046
Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL)
An observational study of Persistent Polyclonal B-Cell Lymphocytosis, run by Central Hospital, Nancy, France at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Polyclonal B-Cell Lymphocytosis
- What is being tested?
- Blood test
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Nov 2012to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PPBL patients in France
Who may be able to join
- PPBL diagnosis established during a previous medical visit
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
France2 sites
group GFHC and intergroup LLC (GCFLL-MW / GOELAMS)
Marseille
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy
About this study
Official title: Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL) - Observatory 1990-2012
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.
- Being tested
- Blood test
- Medical subject headings
- Persistent Polyclonal B-Cell Lymphocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
30 ml
| Study group | Role | What they receive |
|---|---|---|
| PPBL patients | Not described Receives: Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relevant medical history
Measured: Baseline
Complete blood count
Measured: Baseline
Administration of first-line treatment or not
Measured: Baseline
Secondary outcomes (1)
Lymphocyte phenotype
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start13 Nov 2012
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Polyclonal B-Cell LymphocytosisStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296046
- Sponsor's protocol ID
- 2011/PSS/LPLB/LESESVE//MS
- Acronym
- LPLB
- Status last verified
- Sep 2017
- First submitted
- 22 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL) - Observatory 1990-2012
- ClinicalTrials.gov ID
- NCT03296046
- Acronym / sponsor ID
- LPLB / 2011/PSS/LPLB/LESESVE//MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 13 Nov 2012 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 28 Sep 2017 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPBL patients | – | Biological: Blood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PPBL patients in France
Key inclusion criteria (1 listed)
- PPBL diagnosis established during a previous medical visit
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test30 ml | Biological | PPBL patients |
Primary outcome
Relevant medical history
Time frame: Baseline
Complete blood count
Time frame: Baseline
Administration of first-line treatment or not
Time frame: Baseline
1 secondary outcome
Lymphocyte phenotype
Time frame: Baseline
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 28 Sep 2017.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Polyclonal B-Cell Lymphocytosis, run by Central Hospital, Nancy, France at 2 sites in France.
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 1 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 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Relevant medical history (time frame: Baseline). The study lists 3 primary outcomes in all. 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 28 Sep 2017.