Abuse, ChildNCT05626465
Biomarker-s of Abusive Head Trauma by Proteomics
An observational study of Abuse, Child and Protein Disorder, Blood, run by University Hospital, Geneva at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Abuse, Child, Protein Disorder, Blood
- What is being tested?
- Blood test
- How many people
- 174 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2023to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infant between 0 to 2 y.o
Who may be able to join
- 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
Who cannot join
- Refused informed consent
- For control groups : medical history of child abuse
- For AHT group : rare metabolic disease (Menkes, etc..)
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
France1 site
Ginhoux Thiphanie
Lyon, Rhône, 69677
Thiphanie Ginhoux, +33(0)4 27 85 77 23, tiphanie.ginhoux01@chu-lyon.fr
Switzerland1 site
Wiskott Kim
Geneva
Kim Wiskott, kim.wiskott@hcuge.ch
Sergio Manzano
About this study
Official title: Identification of Novel Biomarker-s of Abusive Head Trauma on Serum by Proteomics
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.
- Conditions
- Abuse, Child, Protein Disorder, Blood
- Being tested
- Blood test
- Keywords
- abusive head trauma, proteomic, biomarker
- Medical subject headings
- Blood Protein Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
Proteomic analyses on serum
| Study group | Role | What they receive |
|---|---|---|
| Abusive Head Trauma (AHT) | Not described Receives: Other: Blood test | |
| Accidental traumatic brain injury | Not described Receives: Other: Blood test | |
| Cranioplasty | Not described Receives: Other: Blood test | |
| Infant malaise without AHT | Not described Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Hospital admission to discharge (up to 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study startFeb 2023 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abuse, ChildStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Principal investigator, Kim Wiskott, University Hospital, Geneva
- Investigators
- Tony Fracasso, Prof., Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626465
- Sponsor's protocol ID
- 2021-01971
- Status last verified
- Jan 2023
- First submitted
- 15 Nov 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Novel Biomarker-s of Abusive Head Trauma on Serum by Proteomics
- ClinicalTrials.gov ID
- NCT05626465
- Acronym / sponsor ID
- 2021-01971
- Conditions
- Abuse, Child, Protein Disorder, Blood
- Keywords
- abusive head trauma, proteomic, biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infant between 0 to 2 y.o
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Refused informed consent
- For control groups : medical history of child abuse
- For AHT group : rare metabolic disease (Menkes, etc..)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testProteomic analyses on serum | Other | Abusive Head Trauma (AHT), Accidental traumatic brain injury, Cranioplasty, Infant malaise without AHT |
Primary outcome
Highlight novel biomarker-s of AHT
Time frame: Hospital admission to discharge (up to 3 days)
Proteomic analyses will be made on serum of infant victim of AHT. Results will be compare with control groups (traumatic brain injury, cranioplasty, malaise).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tony Fracasso, Prof. study director
University Hospital, Geneva
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abuse, Child and Protein Disorder, Blood, run by University Hospital, Geneva at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim Wiskott, MD (0041797737424, kim.wiskott@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highlight novel biomarker-s of AHT (time frame: Hospital admission to discharge (up to 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.