Biomarker-s of Abusive Head Trauma by Proteomics | NCT05626465

Studies
Biomarker-s of Abusive Head Trauma by Proteomics

NCT05626465

Sponsor

University Hospital, Geneva

Status

Not yet recruiting

Last Update Posted

Jan 13, 2023Actual

Enrollment

174Estimated

Phase

Not provided

Conditions

Abuse, Child
Protein Disorder, Blood

Interventions

Blood test

Countries

France
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2023Estimated

Primary Completion Date

Feb 2028Estimated

Completion Date

Feb 2028Estimated

First Submitted Date

Nov 15, 2022

First Submission Date that Met QC Criteria

Nov 15, 2022

First Posted Date

Nov 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2023

Last Update Posted Date

Jan 13, 2023Actual

Name	Class
Hospices Civils de Lyon	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of our study is to highlight biomarker-s of Abusive Head Trauma by proteomics analyses on the serum of child victims of abuse.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

174Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abusive Head Trauma (AHT)			Other: Blood test
Accidental traumatic brain injury			Other: Blood test
Cranioplasty			Other: Blood test
Infant malaise without AHT			Other: Blood test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood test	Other	Proteomic analyses on serum	Abusive Head Trauma (AHT) Accidental traumatic brain injury Cranioplasty Infant malaise without AHT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Highlight novel biomarker-s of AHT	Proteomic analyses will be made on serum of infant victim of AHT. Results will be compare with control groups (traumatic brain injury, cranioplasty, malaise).	Hospital admission to discharge (up to 3 days)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age : 0-2 y.o
Medical consultation for malaise, seizure (without fever), loss of consciousness, traumatic bain injury, or cranioplasty
Blood test during medical care
Accepted informed consent

Exclusion Criteria:

Refused informed consent
For control groups : medical history of child abuse
For AHT group : rare metabolic disease (Menkes, etc..)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Years

Standard Ages

Child

Study Population

Infant between 0 to 2 y.o

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kim Wiskott, MD	Contact	0041797737424		kim.wiskott@hcuge.ch

Overall Officials

Name	Affiliation	Role
Tony Fracasso, Prof.	University Hospital, Geneva	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ginhoux Thiphanie		Lyon	Rhône	69677	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001796	Blood Protein Disorders

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided