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NCT Number: NCT06734000

Cohorte COSCINUS - Biocollection

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location status: Recruiting

Location contact

Chloé LEFEVRE, PH

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Dosage of urinary polyunsaturated fatty acid derivatives

    Time frame: 5 years

    Urinary biocollection: correlate the evolution of urinary PUFAs and urinary microbiota with the type of neurovessel, mictional mode, complications, notably infectious, and response to treatment of neurogenic detrusor overactivity (anticholinergic, intra-detrusor botulinum toxin) through data sets: lower urinary tract function, lower urinary tract urodynamics, urinary infections, urinary tree imaging and bladder toxin injection follow-up.

  2. Analysis of fecal polyunsaturated fatty acid derivatives

    Time frame: 5 years

    Fecal biocollection: correlate evolution of fecal microbiota and evolution of polyunsaturated fatty acids in stool with severity of digestive disorders using the International Spinal Cord Injury and Bowel Function data set including the Neurogenic Bowel Dysfunction score.

  3. Analysis of the blood biomarker's evolution in individuals with a spinal cord injury from the injury

    Time frame: 5 years

    Blood biocollection: correlating bone resorption markers with fracture datasets and immunological status with Autonomic nervous system and antibiotic therapy datasets

  4. Analysis of the biomarker's evolution in individuals with a spinal cord injury from the injury

    Time frame: 5 years

    This longitudinal analysis will correlate the evolution of biomarkers reflecting neurological and systemic impairments with their severity and treatment response, including the patient's neurological status (neurological level of the lesion, completeness, and evolution assessed by ISNCSCI)

Study contacts

Contact information is provided by the study sponsor or research team.

Brigitte Perrouin Verbe

CONTACT

[email protected]

+33 2 53 48 28 35

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Cohorte COSCINUS - Biocollection COhort in Spinal Cord Injury - Nantes Follow-Up Standardization

Acronym: COSCINUS

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
Dec 13, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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