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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02056-41 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Angers University | OTHER |
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Metabolic steatosis disease (NAFLD) is a rapidly growing disease in the world, particularly in industrialized countries.
NAFLD is defined by the presence of fatty liver disease. This is a reversible phenomenon that can be estimated by non-invasive means, such as ultrasound. Non-invasive quantification, on the other hand, requires MRI.
Nonalcoholic steatohepatitis (NASH) is the aggressive form of the disease that promotes the accumulation of fibrosis in the liver, which can progress to cirrhosis and its complications.
Currently there is no non-invasive biomarker of NASH and the diagnosis is based solely on liver biopsy.
There is therefore a need for non-invasive biomarkers of NASH in patients with steatosis to diagnose NASH without the use of liver biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative MRI sequences | Device | additional sequences during MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the diagnostic performance of new MRI biomarkers for NASH diagnosis | NASH is defined by histological criteria | the outcome measurment is performed once during MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anita PAISANT, MD | Contact | 0241353637 | +33 | anita.paisant@chu-angers.fr |
| Anthéa LOIEZ | Contact | 0241353637 | +33 | anthea.loiez@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anita PAISANT, MD | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Angers | Recruiting | Angers | France | 49000 | France |
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
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| CHU de Rennes | Recruiting | Rennes | 35033 | France |
|