Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572046
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
STOP-HSPNet a Registry for Hereditary Spastic Paraplegia as an Integration Tool for Future Therapeutic Strategies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
STOP-HSPNet a Registry for Hereditary Spastic Paraplegia as an Integration Tool for Future Therapeutic Strategies
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our goal is to create a solid and harmonious disease registry of patient affected by hereditary spastic paraplegia HSP that facilitates the collection and management of patients data over time encouraging the research and the development of future clinical trials In-depth clinical phenotyping will develop significant clinical outcome measures that can be used in clinical trials and will allow the phenotypic complexity of the disease to be captured with the use of validated clinical scales biomarkers and so-called patient reported outcomes PROs
Detailed Description:
The registry will involve five recruiting clinical centres IRCCS Fondazione Stella Maris in Pisa IRCCS Eugenio Medea in Conegliano IRCCS Policlinico Gemelli in Rome IRCCS Istituto di Scienze Neurologiche in Bologna Università degli studi di Messina and a data analysis partner CINECA
Participants will be assessed annually at one of the five participating clinical sites For each patient at least one follow-up visit will be scheduled at an interval of 12 months in order to monitor and compare the longitudinal progression of HSP in similar groups for example based on phenotype age at onset or genotype At each visit all enrolled subjects will carry out a clinical-instrumental evaluation as per clinical practice including anamnestic collection general and neurological objective examination administration of illness scales eg the SPRS scale and quality of life questionnaires Any biological samples will be collected as tissues blood or urine and stored in the laboratories or bio-repositories of the individual centers and also reported in the electronic clinical report form CRF of STOP-HSPnet The results of further diagnostic tests carried out such as Optical coherence tomography OCT brain magnetic resonance imaging MRI or neurophysiology performed during diagnostic practice or clinical follow up will also be collected Any further clinical scalesevaluation questionnaires to be administered will be selected according to clinical need based on the neurological characteristics and genotype of each participant All data relating to further instrumental andor neurophysiological investigations carried out by the patient for clinical needs will also be collected
The data collected during the aforementioned clinical-instrumental-laboratory evaluations will be entered into the STOP-HSPnet register in pseudonymized form
Participants will be assessed annually at one of the five participating clinical sites For each patient at least one follow-up visit will be scheduled at an interval of 12 months in order to monitor and compare the longitudinal progression of HSP in similar groups for example based on phenotype age at onset or genotype At each visit all enrolled subjects will carry out a clinical-instrumental evaluation as per clinical practice including anamnestic collection general and neurological objective examination administration of illness scales eg the SPRS scale and quality of life questionnaires Any biological samples will be collected as tissues blood or urine and stored in the laboratories or bio-repositories of the individual centers and also reported in the electronic clinical report form CRF of STOP-HSPnet The results of further diagnostic tests carried out such as Optical coherence tomography OCT brain magnetic resonance imaging MRI or neurophysiology performed during diagnostic practice or clinical follow up will also be collected Any further clinical scalesevaluation questionnaires to be administered will be selected according to clinical need based on the neurological characteristics and genotype of each participant All data relating to further instrumental andor neurophysiological investigations carried out by the patient for clinical needs will also be collected
The data collected during the aforementioned clinical-instrumental-laboratory evaluations will be entered into the STOP-HSPnet register in pseudonymized form
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