Ignite Creation Date:
2024-05-06 @ 8:56 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02869074
Status:
UNKNOWN
Last Update Posted:
2020-03-20
First Post:
2016-07-29
Brief Title:
Molecular and Clinical Profile of Von Willebrand Disease in Spain
Sponsor:
Spanish Society of Thrombosis and Haemostasis
Organization:
Spanish Society of Thrombosis and Haemostasis
Study Overview
Official Title:
Molecular and Clinical Profile of Von Willebrand Disease VWD in Spain PCM-EVW-ES Recruitment Extension Further Data Analysis Improvement of Registry Platform Diagnosis and Management of VWD Application Development
Status:
UNKNOWN
Status Verified Date:
2020-03
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:
PCM-EVW-ES
Brief Summary:
The present Project is a third phase of the previous PCM-EVW-ES Project Batlle et al Thromb Haemost 2015 with the aim of its extension further analysis with an innovation development in the field of von Willebrand disease VWD based in the newer recently available methodologies The aim of this project is to help the physician in a more uniform characterization and therapy of VWD in clinical practice at an international level A reduction of the expenses in the diagnosis process by using the new methodologies is pursued
Detailed Description:
The present Project is a third phase of the previous PCM-EVW-ES Project Batlle et al Thromb Haemost 2015 with the aim of its extension further analysis with an innovation development in the field of von Willebrand disease VWD based in the newer recently available methodologies The aim of this project is to help the physician in a more uniform characterization and therapy of VWD in clinical practice at an international level A reduction of the expenses in the diagnosis process by using the new methodologies is pursued
The specific objectives and corresponding tasks of the present project are as follows
1 Extension of the central phenotypic and next generation sequencing NGS genotypic characterization of the VWD in Spain through the prospective recruitment in the Spanish VWD cohort of approximately 500 new patients with local historical VWD diagnosis from approximately 38 centres
i Improvement of the registry portal and database ii Recruitment criteria phenotypic and genetic analysis of new recruited patients In silico studies of novel von Willebrand factor gene VWF mutations iii Analysisinvestigation of the potential interrelationship between different clinical phenotypic and genetic variations of the all recruited patients iv Validationconfirmation of the PCM-EVW-ES of the new initial diagnostic proposed algorithm including VWF NGS analysis This project involves leading innovation and translational research with a direct impact on the quality of clinical care applicability To our knowledge there is no similar project in this field Potential patents may derive from this project It involves also development of e-learning and new information technologies debates forum ads google search engine This project may promote international collaboration
Development of an algorithmic platform that facilitates diagnosis and therapy orientation of VWD in clinical practice using the selected data from the overwhelming amount of information that new technologies such as NGS are producing
The specific objectives and corresponding tasks of the present project are as follows
1 Extension of the central phenotypic and next generation sequencing NGS genotypic characterization of the VWD in Spain through the prospective recruitment in the Spanish VWD cohort of approximately 500 new patients with local historical VWD diagnosis from approximately 38 centres
i Improvement of the registry portal and database ii Recruitment criteria phenotypic and genetic analysis of new recruited patients In silico studies of novel von Willebrand factor gene VWF mutations iii Analysisinvestigation of the potential interrelationship between different clinical phenotypic and genetic variations of the all recruited patients iv Validationconfirmation of the PCM-EVW-ES of the new initial diagnostic proposed algorithm including VWF NGS analysis This project involves leading innovation and translational research with a direct impact on the quality of clinical care applicability To our knowledge there is no similar project in this field Potential patents may derive from this project It involves also development of e-learning and new information technologies debates forum ads google search engine This project may promote international collaboration
Development of an algorithmic platform that facilitates diagnosis and therapy orientation of VWD in clinical practice using the selected data from the overwhelming amount of information that new technologies such as NGS are producing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None