Clinical trial NCT06734000: Cohorte COSCINUS - Biocollection
Official title: Cohorte COSCINUS - Biocollection COhort in Spinal Cord Injury - Nantes Follow-Up Standardization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injury
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 105
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals with spinal cord injury admitted to the neurological PRM department of the Nantes University Hospital at the initial phase of development of the paraplegia or tetraplegia could participate, regardless the clinical neurological status.

Brief summary: COSCINUS is a standardized framework for evaluating temporal trends in SCI causes, SCI characteristics, and demographic patterns. It allows a precise estimation of medical complications' incidence, their evolution over time, as well risk factors influencing these complications, including management modalities. Moreover, COSCINUS provides a high-quality research platform, including clinical, epidemiological, biostatistical, and IT expertise, thereby promoting fundamental research in spinal cord injury and related autonomic dysfunctions. As a national epidemiological tool, COSCINUS offers unique analytical perspectives, promising significant contributions to the understanding and management of spinal cord injuries.

Detailed description: The Neurological Physical and Rehabilitation Medicine (NPRM) Department at Nantes University Hospital, referral centre for SCI patients, has been working since 2015 on the creation of a comprehensive database. This database systematically collects a wide range of data, including socio-demographic, clinical, health status, activity and participation data for SCI patients.

Paired with this database is a longitudinal biocollection that preserves blood, urinary, and feces samples enabling analyses of the microbiome, biomarkers as metabolic, inflammatory, immune, and injury severity biomarkers.

The COSCINUS cohort and its biocollection, created through a multidisciplinary approach, are longitudinally structured. They entail meticulous and continuous recording of standardized data and specific sample collection across various phases of spinal cord injury management, from the acute phase through long-term follow-up.

Data and samples are collected prospectively at specific time points:

Acute phase, admission to PRM department, 6 months post-injury, discharge and during scheduled follow-up consultations (1 / 2 / 3 years post-injury...) with additional collection in case of complications

Eligibility criteria: Inclusion Criteria:

* All individuals with spinal cord injury admitted to the neurological PRM department of the Nantes University Hospital at the initial phase of development of the paraplegia or tetraplegia could participate, regardless the clinical neurological status.

Exclusion Criteria:

* Patients not covered by social security.

Primary outcomes:
measure: Dosage of urinary polyunsaturated fatty acid derivatives
timeFrame: 5 years
measure: Analysis of fecal polyunsaturated fatty acid derivatives
timeFrame: 5 years
measure: Analysis of the blood biomarker's evolution in individuals with a spinal cord injury from the injury
timeFrame: 5 years
measure: Analysis of the biomarker's evolution in individuals with a spinal cord injury from the injury
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References: