Multiple SclerosisNCT06372977
Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of ms and Prediction of Disease Activity
An observational study of Multiple Sclerosis, run by Assiut University.
Trial summary
To: 1. Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases . 2. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- kappa index
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 2026
- 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 18 to 40 years
- All sexes
- Adult
Study population: we will select for this study 140 patients including control group and patients group aged between 18 -40
Who may be able to join
- Patients diagnosed with CIS or MS according to the 2017 revision of the McDonald criteria
- Patients diagnosed with RIS (Radiological isolated syndrome) according to the criteria by Okuda
- Age between 18 and 40 years.
Who cannot join
- History of exposure, in the 30 days prior to CSF collection, to immunosuppressant or immunomodulatory therapies .
- Peripheral neurological disorders .
- Infectious CNS disease.
- CNS tumor.
- Monoclonal gammopathy .
- Chronic kidney injury (GFR <30 ml /min/1.75m2 )
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of Multiple Sclerosis and Prediction of Disease
To:
- Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases .
- Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis)
Read the detailed description
Multiple sclerosis is a chronic inflammatory immune-mediated disorder of the central nervous system.Diagnosis requires the combination of clinical signs and symptoms with paraclinical findings obtained by magnetic resonance imaging and cerebrospinal fluid analysis .which are componants of the 2017 McDonald criteria .So far, the gold standard for demonstrating intrathecal IgG synthesis is represented by selective oligoclonal bands in cerebrospinal fluid by isoelectric focusing (IEF), alongside an elevated IgG index .However, the detection of oligoclonal bands in cerebrospinal fluid has several limits as , it requires a time-consuming and expensive laboratory technique, with about three hours needed to obtain results Furthermore, it only provides aqualitative information about the presence of IgG in CSF .During CNS inflammation , kappa free light chain are secreted in the CSF and their concentration reflect the degree of intrathecal B cells and plasma cells activation .Measurement of KFLC could help diagnosis of OCB negative MS and identify intrathecal immunoglobulin synthesis in patient presenting with one isolated band on isoelectric focusing , and it is fully automated,rater independent, stable against preanalytical errors . Thus, the intrathecal synthesis of free light chains are more sensitive, less costly, and less time-consuming compared To OCB detection .The most reliable parameter used to assess FLC diagnostic value in MS is the k-index, .So κ-FLC index predicted the time to conversion to MS as well as disability progression . So patients with early MS and high κ-FLC index is an independent risk factor for conversion from CIS to MS
- Conditions
- Multiple Sclerosis
- Being tested
- kappa index
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kappa indexDiagnostic test
CSF albumin /serum albumin ratio (Qalb) k-index = (CSF kFLC/serum kFLC)/Qalb
| Study group | Role | What they receive |
|---|---|---|
| 1 | (-ve OCB )(70 patients) Control group which include patients with inflammatory and non-inflammatory neurological diseases (such as cerebral small vessel disease or unspecific white matter lesion ) Receives: Diagnostic Test: kappa index | |
| 2 | (+ve OCBs )(70 patients) Patients presenting for the diagnostic workup, including CSF analysis , of clinical and/or MRI suspicion of MS or CIS. Receives: Diagnostic Test: kappa index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases .
measure specificity and sensitivity of kappa free light chain
Measured: baseline
Assess the diagnostic performance of CSF IgG OCBs in differentiating MS from other inflammatory and non-inflammatory neurological diseases .
measure specificity and sensitivity of cerebrospinal fluid oligoclonal bands
Measured: baseline
Secondary outcomes (2)
Assess the role of k FLC in predicting disease activity (conversion from CIS to MS)
measure positive predictive value and negative predictive value of kappa free light chain
Measured: baseline
Assess the role of OCBs in predicting disease activity (conversion from CIS to MS)
measure positive predictive value and negative predictive value of oligoclonal bands
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham mohamed ahmed abdelsater, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372977
- Sponsor's protocol ID
- kappa index in ms
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gaetani L, Di Carlo M, Brachelente G, Valletta F, Eusebi P, Mancini A, Gentili L, Borrelli A, Calabresi P, Sarchielli P, Ferri C, Villa A, Di Filippo M. Cerebrospinal fluid free light chains compared to oligoclonal bands as biomarkers in multiple sclerosis. J Neuroimmunol. 2020 Feb 15;339:577108. doi: 10.1016/j.jneuroim.2019.577108. Epub 2019 Nov 7.
PubMed 31743879Duell F, Evertsson B, Al Nimer F, Sandin A, Olsson D, Olsson T, Khademi M, Hietala MA, Piehl F, Hansson M. Diagnostic accuracy of intrathecal kappa free light chains compared with OCBs in MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 11;7(4):e775. doi: 10.1212/NXI.0000000000000775. Print 2020 Jul.
PubMed 32527760
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of Multiple Sclerosis and Prediction of Disease
- ClinicalTrials.gov ID
- NCT06372977
- Acronym / sponsor ID
- kappa index in ms
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Apr 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.
To:
- Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases .
- Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis)
Detailed description
Multiple sclerosis is a chronic inflammatory immune-mediated disorder of the central nervous system.Diagnosis requires the combination of clinical signs and symptoms with paraclinical findings obtained by magnetic resonance imaging and cerebrospinal fluid analysis .which are componants of the 2017 McDonald criteria .So far, the gold standard for demonstrating intrathecal IgG synthesis is represented by selective oligoclonal bands in cerebrospinal fluid by isoelectric focusing (IEF), alongside an elevated IgG index .However, the detection of oligoclonal bands in cerebrospinal fluid has several limits as , it requires a time-consuming and expensive laboratory technique, with about three hours needed to obtain results Furthermore, it only provides aqualitative information about the presence of IgG in CSF .During CNS inflammation , kappa free light chain are secreted in the CSF and their concentration reflect the degree of intrathecal B cells and plasma cells activation .Measurement of KFLC could help diagnosis of OCB negative MS and identify intrathecal immunoglobulin synthesis in patient presenting with one isolated band on isoelectric focusing , and it is fully automated,rater independent, stable against preanalytical errors . Thus, the intrathecal synthesis of free light chains are more sensitive, less costly, and less time-consuming compared To OCB detection .The most reliable parameter used to assess FLC diagnostic value in MS is the k-index, .So κ-FLC index predicted the time to conversion to MS as well as disability progression . So patients with early MS and high κ-FLC index is an independent risk factor for conversion from CIS to MS
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: kappa index(-ve OCB )(70 patients) Control group which include patients with inflammatory and non-inflammatory neurological diseases (such as cerebral small vessel disease or unspecific white matter lesion ) |
| 2 | – | Diagnostic Test: kappa index(+ve OCBs )(70 patients) Patients presenting for the diagnostic workup, including CSF analysis , of clinical and/or MRI suspicion of MS or CIS. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- we will select for this study 140 patients including control group and patients group aged between 18 -40
Key inclusion criteria (3 listed)
- Patients diagnosed with CIS or MS according to the 2017 revision of the McDonald criteria
- Patients diagnosed with RIS (Radiological isolated syndrome) according to the criteria by Okuda
- Age between 18 and 40 years.
Key exclusion criteria (6 listed)
- History of exposure, in the 30 days prior to CSF collection, to immunosuppressant or immunomodulatory therapies .
- Peripheral neurological disorders .
- Infectious CNS disease.
- CNS tumor.
- Monoclonal gammopathy .
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 |
|---|---|---|
| kappa indexCSF albumin /serum albumin ratio (Qalb) k-index = (CSF kFLC/serum kFLC)/Qalb | Diagnostic test | 1, 2 |
Primary outcome
Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases .
Time frame: baseline
measure specificity and sensitivity of kappa free light chain
Assess the diagnostic performance of CSF IgG OCBs in differentiating MS from other inflammatory and non-inflammatory neurological diseases .
Time frame: baseline
measure specificity and sensitivity of cerebrospinal fluid oligoclonal bands
2 secondary outcomes
Assess the role of k FLC in predicting disease activity (conversion from CIS to MS)
Time frame: baseline
Assess the role of OCBs in predicting disease activity (conversion from CIS to MS)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Background: PubMed 31743879Gaetani L, Di Carlo M, Brachelente G, Valletta F, Eusebi P, Mancini A, Gentili L, Borrelli A, Calabresi P, Sarchielli P, Ferri C, Villa A, Di Filippo M. Cerebrospinal fluid free light chains compared to oligoclonal bands as biomarkers in multiple sclerosis. J Neuroimmunol. 2020 Feb 15;339:577108. doi: 10.1016/j.jneuroim.2019.577108. Epub 2019 Nov 7.
- Background: PubMed 32527760Duell F, Evertsson B, Al Nimer F, Sandin A, Olsson D, Olsson T, Khademi M, Hietala MA, Piehl F, Hansson M. Diagnostic accuracy of intrathecal kappa free light chains compared with OCBs in MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 11;7(4):e775. doi: 10.1212/NXI.0000000000000775. Print 2020 Jul.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Assiut University.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact reham abdelsater, assistant lecturer (01024478076, rehamabdelsater@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases . (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06372977, which also lists 2 linked publications.
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 18 Apr 2024.