Study of Immune Thrombocytopenia Pathogenesis:

Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.

Patrocinadores

Patrocinador principal: Centre Hospitalier Universitaire Dijon

Fuente Centre Hospitalier Universitaire Dijon
Resumen breve

Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.

The aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.

Estado general Completed
Fecha de inicio May 4, 2011
Fecha de Terminación March 12, 2015
Fecha de finalización primaria March 12, 2015
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
blood level T cell in ITP patients and in healthy controls baseline
blood level T cell in ITP patients after treatments change from baseline at 4 to 8 weeks
Resultado secundario
Medida Periodo de tiempo
blood level splenic T cell in ITP patients and in healthy controls baseline
frequency of innate immune cells (dendritic cells, monocytes, NK cells…) and their functions in blood and spleens, in patients and in controls through study completion, an average of 3 years
level of T follicular helper cell through study completion, an average of 3 years
Inscripción 89
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: Blood samples

Tipo de intervención: Other

Nombre de intervención: Spleen samples

Etiqueta de grupo de brazo: Patients with ITP

Elegibilidad

Método de muestreo: Probability Sample

Criterios:

Inclusion Criteria:

- Patients with ITP, defined as thrombocytopenia < 30 G/L, once causes related to infection, medication, systemic auto-immune disease or malignant hemopathy have been ruled out

- persons who have provided written informed consent

Exclusion Criteria:

- persons without national health insurance

- persons under 18 years old

- patients under guardianship

- pregnancy

- subjects suffering from a systemic auto-immune disease, cancer, a progressive infection, or treated with steroids or immunosuppressants.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: Accepts Healthy Volunteers

Ubicación
Instalaciones:
CHU de Besançon | Besançon, 25000, France
CHU de Dijon | Dijon, 21079, France
CHU de METZ | Metz, 57000, France
Ubicacion Paises

France

Fecha de verificación

March 2018

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Patients with ITP

Etiqueta: Controls

Acrónimo PTI PARI
Información de diseño del estudio

Modelo de observación: Case-Control

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov