NCT04071496

Brief Summary

The objective of this study is to provide simple and relevant clinical and biological elements to distinguish a possible Congenital Thrombocytopenia from a Chronic Idiopathic Thrombocytopenic Purpura .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

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 25, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2012

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

August 23, 2019

Last Update Submit

August 26, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Modelization of congenital thrombocytopenia test

    Taking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)

    AT the screening

  • Modelization of chronic idiopathic thrombocytopenic purpura test

    Taking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)

    AT the screening

Interventions

1 dry tube of 5 ml, 3 citrated tubes of 5 ml, 1 tube citrate dextrose acid of 7 ml

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Congenital Thrombocytopenia Patients and Chronic Idiopathic Thrombocytopenic Purpura Patients

You may qualify if:

  • All patients with chronic thrombocytopenia (\> 6 months) between 10 and 150 G / L, regardless of age or gender,
  • Subjects with a definite Chronic Idiopathic thrombocytopenic purpuras, - Subjects with a certain degree of certainty, sometimes pre-identified and already known at the level of the C reactive protein,
  • Subjects with chronic thrombocytopenia of undetermined origin, not definitively entering one of the 2 groups mentioned above.

You may not qualify if:

  • Thrombocytopenia less than 6 months old;
  • Patients with thrombocytopenia related to a viral or chronic infectious pathology (HIV infections or hepatitis C virus, bacterial infections with Helicobacter pillory, for example), an autoimmune disease, in particular systemic lupus and / or antiphospholipid syndrome, a bleeding disorder such as a Intra-vascular Disseminated coagulation, thrombotic microangiopathy, hypersplenism, a responsible medication intake, myelodysplastic syndrome, a pregnancy in progress.
  • Patients should not be treated with Immunoglobulin IV, rituximab or anti-CD20 less than 30 days before the date of collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

1 dry tube of 5 ml, 3 citrated tubes of 5 ml, 1 tube citrate dextrose acid of 7 ml

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Paquita NURDEN, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

November 25, 2009

Primary Completion

March 12, 2012

Study Completion

March 12, 2012

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share