Central Nervous System DiseasesNCT05088473
Diagnosic and Pronostic Values of Kappa and Lambda Free Light Chains in Central Nervous System Inflammatory Diseases
An observational study of Central Nervous System Diseases and Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nice at 14 sites in France.
Trial summary
Numerous studies have shown the diagnostic interest of cerebrospinal fluid kappa free light chains and kappa index in multiple sclerosis. However, large cohort studies are lacking and little is known about the correlation between kappa and lambda indexes and multiple sclerosis evidence disease activity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Nervous System Diseases, Multiple Sclerosis
- What is being tested?
- Biological collection
- How many people
- 1,500 participants
- Where
- 14 sitesFrance
- Study dates
- 15 Oct 2021to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting with symptoms evocative of CNS disease
Who may be able to join
- Patients presenting with symptoms evocative of CNS involvement for who serum and cerebrospinal fluid kappa free light chains and kappa index are available
Who cannot join
- Infectious CNS disease
- Tumor CNS disease
- Active CNS bleeding
- Monoclonal gammapathy
- Severe chronic renal failure (glomerular filtration rate <30 ml/mn)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand
Centre Hospitalier Universitaire de Dijon
Dijon
Centre Hospitalier Universitaire de Grenoble
Grenoble
Centre Hospitalier Universitaire de Lille
Lille
Assistance Publique des Hôpitaux de Marseille
Marseille
Centre Hospitalier Universitaire de Montpellier
Montpellier
Centre Hospitalier Universitaire de Nantes
Nantes
Centre Hospitalier Universitaire de Nice
Nice
Centre Hospitalier Universitaire de Nîmes
Nîmes
Assistance Publique des Hôpitaux de Paris
Paris
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne
Centre Hospitalier Universitaire de Strasbourg
Strasbourg
Centre Hospitalier Universitaire de Toulouse
Toulouse
Centre Hospitalier Régional et Universaitaire de Tours
Tours
About this study
Numerous studies have shown the diagnostic interest of cerebrospinal fluid kappa free light chains and kappa index in multiple sclerosis. However, large cohort studies are lacking and little is known about the correlation between kappa and lambda indexes and multiple sclerosis evidence disease activity. Therefore, this study plan to validate the kappa and lambda free light chains and indexes as diagnostic biomarker in multiple sclerosis and to correlate the concentration of kappa and lambda free light chains with clinical and radiological activity in a large cohort of patients.
- Being tested
- Biological collection
- Keywords
- multiple sclerosis, kappa free light chains, lambda free light chains
- Medical subject headings
- Central Nervous System Diseases, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological collectionOther
Collection of cerebrospinal fluid kappa and lambda free light chains and indexes
| Study group | Role | What they receive |
|---|---|---|
| Mutliple sclerosis | Not described Receives: Other: Biological collection | |
| CIS/RIS | Not described Receives: Other: Biological collection | |
| Other CNS inflammatory diseases | Not described Receives: Other: Biological collection | |
| Non inflammatory CNS diseases | Not described Receives: Other: Biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of cerebrospinal fluid (CSF) and serum kappa and lambda free light chains (KFLC and LFLC)
- Measurement of cerebrospinal fluid (CSF) and serum KFLC and LFLC by a turbilimetric analyzer (data in mg/L)
- Quantification of QKFLC and QLFLC (CSF FLC/serum FLC) in each group of patients
- Compare median of QKFLC and QLFLC between groups
Measured: 1 day
Measurement of cerebrospinal fluid (CSF) and serum albumin
- Measurement of cerebrospinal fluid (CSF) and serum albumin by the same turbilimetric analyzer (data in mg/L)
- Quantification of albumin quotient (AQ) (CSF albumin/serum albumin) in each group of patients
Measured: 1 day
Evaluation of the diagnostic performances of KFLC and LFLC intrathecal synthesis biomarkers (K/L FLC index and K/L FLC intrathecal fraction (IF)) for multiple sclerosis
- Calculation of KFLC intrathecal synthesis biomarkers: KFLC index = (CSF KFLC/serum KFLC) / AQ KFLC IF = (KFLC(loc)/CSF KFLC) x 100 with: KFLC(loc) = ((CSF KFLC/serum KFLC) / Qk(lim)) x serum KFLC and Qk(lim) = 3.27 x (AQ^2 + 33)^0.5 - 8.2
- Calculation of LFLC intrathecal synthesis biomarkers: LFLC index = (CSF LFLC/serum LFLC) / AQ) LFLC IF = (LFLC(loc)/CSF LFLC) x 100 with: LFLC(loc) = ((CSF LFLC/serum LFLC) / Ql(lim)) x serum LFLC and Ql(lim) = 2.1138 x AQ^0.865
- Determination of diagnostic performances by ROC curve analysis and best cut-off values with the Younden index to calculate sensitivity, specificity and predictive values for MS diagnosis
Measured: 1 day
Comparison of diagnostic performances of K/L FLC intrathecal synthesis biomarkers to oligoclonal bands (OCB) for multiple sclerosis
- Identification of OCB status for each patient
- Calculation of diagnostic performances of OCB (sensitivity, specificity and predictive values) for MS diagnostic
- Comparison of diagnostic performances (sensitivity, specificity and predictive values) of OCB and K/L FLC intrathecal synthesis biomarkers for multiple sclerosis
Measured: 1 day
Secondary outcomes (1)
Evaluation of clinical data that can alter KFLC and LFLC values
Identification of data that can be independtly associated with high or low CSF KFLC or LFLC values as potential bias in K/L FLC intrathecal synthesis biomarkers interpretation:
- Gender
- Age
- Type of clinical demyelinating event (i.e. myelitis, optic neuritis...)
- Immune modifying drug treatment ongoing during sampling
- Underlying disease activity (measured by the presence of subacute clinical symptoms ongoing at sampling or gadolinium enhanced lesions within the last MRI status)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start15 Oct 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088473
- Sponsor's protocol ID
- 21Neuro01
- Status last verified
- Nov 2021
- First submitted
- 13 Jul 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosic and Pronostic Values of Kappa and Lambda Free Light Chains in Central Nervous System Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT05088473
- Acronym / sponsor ID
- 21Neuro01
- Keywords
- multiple sclerosis, kappa free light chains, lambda free light chains
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 22 Oct 2021 (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.
Numerous studies have shown the diagnostic interest of cerebrospinal fluid kappa free light chains and kappa index in multiple sclerosis. However, large cohort studies are lacking and little is known about the correlation between kappa and lambda indexes and multiple sclerosis evidence disease activity. Therefore, this study plan to validate the kappa and lambda free light chains and indexes as diagnostic biomarker in multiple sclerosis and to correlate the concentration of kappa and lambda free light chains with clinical and radiological activity in a large cohort of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mutliple sclerosis | – | Other: Biological collection |
| CIS/RIS | – | Other: Biological collection |
| Other CNS inflammatory diseases | – | Other: Biological collection |
| Non inflammatory CNS diseases | – | Other: Biological collection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting with symptoms evocative of CNS disease
Key inclusion criteria (1 listed)
- Patients presenting with symptoms evocative of CNS involvement for who serum and cerebrospinal fluid kappa free light chains and kappa index are available
Key exclusion criteria (5 listed)
- Infectious CNS disease
- Tumor CNS disease
- Active CNS bleeding
- Monoclonal gammapathy
- Severe chronic renal failure (glomerular filtration rate <30 ml/mn)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological collectionCollection of cerebrospinal fluid kappa and lambda free light chains and indexes | Other | CIS/RIS, Mutliple sclerosis, Non inflammatory CNS diseases, Other CNS inflammatory diseases |
Primary outcome
Measurement of cerebrospinal fluid (CSF) and serum kappa and lambda free light chains (KFLC and LFLC)
Time frame: 1 day
1. Measurement of cerebrospinal fluid (CSF) and serum KFLC and LFLC by a turbilimetric analyzer (data in mg/L) 2. Quantification of QKFLC and QLFLC (CSF FLC/serum FLC) in each group of patients 3. Compare median of QKFLC and QLFLC between groups
Measurement of cerebrospinal fluid (CSF) and serum albumin
Time frame: 1 day
1. Measurement of cerebrospinal fluid (CSF) and serum albumin by the same turbilimetric analyzer (data in mg/L) 2. Quantification of albumin quotient (AQ) (CSF albumin/serum albumin) in each group of patients
Evaluation of the diagnostic performances of KFLC and LFLC intrathecal synthesis biomarkers (K/L FLC index and K/L FLC intrathecal fraction (IF)) for multiple sclerosis
Time frame: 1 day
1. Calculation of KFLC intrathecal synthesis biomarkers: KFLC index = (CSF KFLC/serum KFLC) / AQ KFLC IF = (KFLC(loc)/CSF KFLC) x 100 with: KFLC(loc) = ((CSF KFLC/serum KFLC) / Qk(lim)) x serum KFLC and Qk(lim) = 3.27 x (AQ^2 + 33)^0.5 - 8.2 2. Calculation of LFLC intrathecal synthesis biomarkers: LFLC index = (CSF LFLC/serum LFLC) / AQ) LFLC IF = (LFLC(loc)/CSF LFLC) x 100 with: LFLC(loc) = ((CSF LFLC/serum LFLC) / Ql(lim)) x serum LFLC and Ql(lim) = 2.1138 x AQ^0.865 3. Determination of diagnostic performances by ROC curve analysis and best cut-off values with the Younden index to calculate sensitivity, specificity and predictive values for MS diagnosis
Comparison of diagnostic performances of K/L FLC intrathecal synthesis biomarkers to oligoclonal bands (OCB) for multiple sclerosis
Time frame: 1 day
1. Identification of OCB status for each patient 2. Calculation of diagnostic performances of OCB (sensitivity, specificity and predictive values) for MS diagnostic 3. Comparison of diagnostic performances (sensitivity, specificity and predictive values) of OCB and K/L FLC intrathecal synthesis biomarkers for multiple sclerosis
1 secondary outcome
Evaluation of clinical data that can alter KFLC and LFLC values
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Diseases and Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nice at 14 sites 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 5 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: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of cerebrospinal fluid (CSF) and serum kappa and lambda free light chains (KFLC and LFLC) (time frame: 1 day). 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 9 Nov 2021.