Ignite Creation Date:
2024-05-06 @ 8:55 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02855034
Status:
RECRUITING
Last Update Posted:
2023-03-13
First Post:
2016-08-01
Brief Title:
Evaluation of Discriminating Power of Two Biomarkers in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Evaluation of Discriminating Power of Two Biomarkers Protein S100BCopeptin in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
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:
TCOP100
Brief Summary:
Head injury is a frequent motive of consultation in paediatric emergency units and the first cause of mortality in infants of more than one year old in developped countries The indication of performing cerebral CT scans currently depends on clinical decision based on recommendations used in adults In this way 60 to 90 of scans are normal in children with head injury CT scan is expensive and irradiating with the risk of increasing the cancer in children Protein S100B and copeptin are biomarkers which have shown their ability to detect cerebral lesion in children with head injury protein S100B and or in adults protein S100B and copetin
It is the first clinical biological evaluation of severity of head injury based on dosing of copeptin alone or associated with protein S100B
Furthermore the evaluation of the biomarkers GFAP NFL Tau and UCHL-1 is today necessary from a scientific point of view and to optimize the diagnostic and prognostic value of these biomarkers which can be combined Indeed these protein biomarkers are biologically linked to the protein S100B and copeptin and will allow a more specific and more thorough evaluation of the presence of brain damage at the cellular level More specifically the measurement of the S-100B and GFAP proteins will allow evaluation of gliovascular damage while those of copeptin NFL Tau and UCHL1 proteins will allow evaluation of neuronal damage The assay of these different biomarkers will also be carried out on a control population without head injury or neurological or inflammatory pathologies in order to establish the standards of these biomarkers on a pediatric population of similar age
It is the first clinical biological evaluation of severity of head injury based on dosing of copeptin alone or associated with protein S100B
Furthermore the evaluation of the biomarkers GFAP NFL Tau and UCHL-1 is today necessary from a scientific point of view and to optimize the diagnostic and prognostic value of these biomarkers which can be combined Indeed these protein biomarkers are biologically linked to the protein S100B and copeptin and will allow a more specific and more thorough evaluation of the presence of brain damage at the cellular level More specifically the measurement of the S-100B and GFAP proteins will allow evaluation of gliovascular damage while those of copeptin NFL Tau and UCHL1 proteins will allow evaluation of neuronal damage The assay of these different biomarkers will also be carried out on a control population without head injury or neurological or inflammatory pathologies in order to establish the standards of these biomarkers on a pediatric population of similar age
Detailed Description:
265 children or infants will be recruited during 84 months 220 patients with a suspicion of head injury and 45 patients without head injury
Each patient will attend a visit of inclusion and a blood sample Just patients with a suspicion of head injury have a visit at 96 hours - 24 hours after the inclusion this visit is made by phone The patient and his parents will have to answer to a phone questionnaire
Each patient will attend a visit of inclusion and a blood sample Just patients with a suspicion of head injury have a visit at 96 hours - 24 hours after the inclusion this visit is made by phone The patient and his parents will have to answer to a phone questionnaire
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-A00553-46 | OTHER | Agence Nationale de Sécurité des Médicaments | None |