Etude : SYTHROM /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : SYTHROM

Situation thérapeutique : Induction

Traitement : Chimiothérapie

Cadre réglementaire : RIPH3

Dernière MÀJ : 29/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Retrospective and Prospective Multicenter Study Evaluating the Impact of Treatment With Cytoreducing Agents on the Recurrence of Thrombosis in Thrombotic Patients With a Diagnosis of Myeloproliferative Neoplasia and Normal Blood Counts - a FIM Study

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C96 - Tumeurs malignes des tissus lymphoïde, hématopoïétique et apparentés, autres et non précisées
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : STUDY DESIGN:
This study is observational and multicentric.In a first part, patients will be retrospectively included. Baseline clinical and biological data obtained at the time of MPN diagnosis of MPN with normal CBC following venous or arterial thrombosis will be recorded and follow-up data will be collected in an e-CRF. In a second part, patients will be included prospectively and diagnostic and follow-up data will be collected. Whether or not to initiate treatment with a cytoreduction treatment is left to the discretion of the clinician.

The objective of this observational study is to evaluate the incidence of recurrence of thrombosis in patients whose thrombotic event revealed an underlying MPN with normal CBC. A comparison of groups treated or not with cytoreductive agents will be performed. Longitudinal monitoring of the patients will provide a better understanding of the nature and kinetics of hematological changes in these patients.

Phase : NA

Stade : NA

1 (hémato)
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Adult ≥18 years old
- Diagnosis of a deep arterial or venous thrombotic event verified by imaging (Doppler or CT scan)
- Diagnosis of MPN with normal CBC according to WHO 2017 criteria characterized by the detection of a molecular abnormality JAK2V617F mutation (regardless of allelic load), CALR or MPL and/or a bone marrow biopsy with abnormalities in favor of MPN.
- Normal blood cell count not suggestive of polycythemia vera (hematocrit<48% and hemoglobin<16g/dL for women; hematocrit<49% and hemoglobin<16.5g/dL for men), essential thrombocythemia (platelets<450 G/L) nor myelofibrosis (white blood cell count<11 G/L, no anemia or erythromyelemia associated with splenomegaly) at the time of the thrombotic event.

Critères de non-inclusion : - Minors (<18 years of age)
- Microcirculation disorders (erythromelalgia, headaches, paresthesia, ischemia of the extremities)
- Superficial or deep arterial or venous thrombosis NOT verified by imaging
- Diagnosis or history of TE, PV or myelofibrosis at time of first thrombotic event
- Diagnosis of mixed myelodysplastic/myeloproliferative syndrome
- Diagnosis of unclassifiable MPN with excess blasts at the onset or signs of myelodysplasia as defined by the WHO 2017 classification
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04539678
Promoteur :
CHU de Nantes
Type de sponsor : Institutionnel
5 allée de l'île gloriette
44000 NANTES

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier de Roubaix - 11 Boulevard Lacordaire - 59100 ROUBAIX

Investigateur :
Docteur Mathieu WEMEAU

TEC / ARC / IDE :
Lisa VILLEQUEY
lisa.villequey@
ch-roubaix.fr
+33 3 20 99 31 31 | DECT 17790

Statut de l'essai : OUVERT

MAJ : 10/06/2021