Spinal Cord InjuryCOSCINUSNCT06734000
Cohorte COSCINUS - Biocollection
An observational study of Spinal Cord Injury, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2024to 10 Oct 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients not covered by social security.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
Chloé LEFEVRE, PH
About this study
Official title: 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.
Read the 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
- Conditions
- Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with spinal cord injury | Collection of blood, urine and feces during the 5 years after the lesion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start13 Dec 2024
- Primary completion10 Oct 2032 (estimated)
- Study completion10 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734000
- Sponsor's protocol ID
- RC24_0413
- Other IDs
- 2024-A01711-46
- Acronym
- COSCINUS
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohorte COSCINUS - Biocollection COhort in Spinal Cord Injury - Nantes Follow-Up Standardization
- ClinicalTrials.gov ID
- NCT06734000
- Acronym / sponsor ID
- COSCINUS / RC24_0413
- Conditions
- Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 10 Oct 2032 (estimated)
- Study completion
- 10 Oct 2032 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with spinal cord injury | – | –Collection of blood, urine and feces during the 5 years after the lesion. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients not covered by social security.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injury
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brigitte Perrouin Verbe (+33 2 53 48 28 35, bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of urinary polyunsaturated fatty acid derivatives (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.