Cohorte COSCINUS - Biocollection (COSCINUS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury

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

• Study Type: Observational
• Enrollment (Estimated): 105

Contacts and Locations

• Study Contact: Name: Brigitte Perrouin Verbe; Phone Number: +33 2 53 48 28 35; Email: bp-prom-regl@chu-nantes.fr

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Recruiting
      • Nantes University Hospital
      • Contact: Chloé LEFEVRE, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Individuals with spinal cord injury; Collection of blood, urine and feces during the 5 years after the lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of the blood biomarker's evolution in individuals with a spinal cord injury from the injury	Blood biocollection: correlating bone resorption markers with fracture datasets and immunological status with Autonomic nervous system and antibiotic therapy datasets	5 years
Analysis of the biomarker's evolution in individuals with a spinal cord injury from the injury	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)	5 years
Dosage of urinary polyunsaturated fatty acid derivatives	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.	5 years
Analysis of fecal polyunsaturated fatty acid derivatives	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.	5 years

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2024
• Primary Completion (Estimated): October 10, 2032
• Study Completion (Estimated): October 10, 2032

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: RC24_0413; 2024-A01711-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No