Cohorte COSCINUS - Biocollection

NCT06734000 | Recruiting

• 2 other identifiers: RC24_04132024-A01711-46
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Study Arms (1)

Individuals with spinal cord injury

Collection of blood, urine and feces during the 5 years after the lesion.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients not covered by social security.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine and stool

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Brigitte Perrouin Verbe

CONTACT

+33 2 53 48 28 35; bp-prom-regl@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: December 13, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): October 10, 2032
• Study Completion (Estimated): October 10, 2032
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

FR (1)