Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04539678
Status:
UNKNOWN
Last Update Posted:
2021-09-09
First Post:
2020-08-31
Brief Title:
SYTHROM Cohort Myeloproliferative Neoplasia With Normal CBC and Thrombotic Complications
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SYTHROM
Brief Summary:
Among the etiologies of thrombosis myeloproliferative neoplasia MPN is quite rare but should be investigated in case of thrombosis of atypical localization digestive or cerebral or in the context of recurrent idiopathic thrombosis in a young subject Thrombosis could reveal an underlying MPN through the identification of a JAK2 V617F mutation Rarely MPN with thrombotic complications present with normal complete blood countCBC In case of a MPN with a thrombotic event but without CBC abnormality anti-thrombotic treatment is recommended But there is no recommendation for the indication of cytoreductive therapy and the clinicians decision is often empirical
One of the major complications of for essential thrombocythemia ET or polycythemia vera PV is thrombosis and an age over 60 is a major risk factor The treatment of thrombosis associated with TE or PV is based on recommendations the main therapeutic objective of which is to reduce the thrombotic risk The combination of a cytoreducing agent and antithrombotic treatment is thus proposed in high-risk patients The efficacy of this management is monitored by assessing CBC with the objective of normalization at 400 GL of platelets for ET patients and 45 hematocrit in case of PV
The absence of abnormal CBC makes it difficult to justify cytoreduction The benefit of such a therapy in this context has not been clinically demonstrated If a cytoreductive therapy is initiated no biological parameters are available to assess the response to treatment
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
One of the major complications of for essential thrombocythemia ET or polycythemia vera PV is thrombosis and an age over 60 is a major risk factor The treatment of thrombosis associated with TE or PV is based on recommendations the main therapeutic objective of which is to reduce the thrombotic risk The combination of a cytoreducing agent and antithrombotic treatment is thus proposed in high-risk patients The efficacy of this management is monitored by assessing CBC with the objective of normalization at 400 GL of platelets for ET patients and 45 hematocrit in case of PV
The absence of abnormal CBC makes it difficult to justify cytoreduction The benefit of such a therapy in this context has not been clinically demonstrated If a cytoreductive therapy is initiated no biological parameters are available to assess the response to treatment
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
Detailed Description:
This study is observational and multicentricIn a first part patients will be retrospectively included Baseline clinical and biological data obtainedat 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None