Assessment of Serum FAM19A5level in Egyptian Patients With NMOSDNCT05446701
Assessment of Serum FAM19A5 Level in Egyptian Patients With Neuromyelitis Optica Spectrum Disorder
An observational study of Assessment of Serum FAM19A5level in Egyptian Patients With NMOSD, run by Assiut University.
Trial summary
Neuromyelitis optica spectrum disorders (NMOSD) are severe inflammatory autoimmune conditions of the central nervous system (CNS) . The discovery of NMOSD-specific aquaporin 4 (AQP4) antibody has established that NMOSD is indeed a distinct entity . Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Assessment of Serum FAM19A5level in Egyptian Patients With NMOSD
- What is being tested?
- serum level of FAM19A5
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to Apr 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Sixty patients diagnosed as NMOSD based on the recently revised 2015 international consensus diagnostic criteria for NMOSD ,attending Neurology clinic, Asyut University hospitals, Asyut university and Kasr Al-Ainy multiple sclerosis/neuroimmunology clinic, Cairo University hospitals, Cairo University, Egypt, through one and half year from study onset. Sixty healthy volunteers, without any neurological or systemic medical diseases, age and sex matched , will be enrolled as healthy controls(HCs).
Who may be able to join
- 1-Both NMOSD AQP-4 +ve and AQP-4 -ve. 2-Age <18 and >60 years. 3-Both males and females. 4-Both receiving or not receiving current immunosuppressants. 5-Any score of extended disability status scale (EDSS).
Who cannot join
- 1-Any neuropsychiatric disorder other than NMOSD such as multiple sclerosis ,CNS infectious diseases or malignancy.
- 2-Systemic conditions influencing analysis of clinical and serological data , such as general infection, malignancy, and hematologic diseases.
- 3-Illiterate patients. 4-History of drug or alcohol abuse
Trial locations and contacts
No sites are listed yet.
About this study
Neuromyelitis optica spectrum disorders (NMOSD) are severe inflammatory autoimmune conditions of the central nervous system (CNS) . The discovery of NMOSD-specific aquaporin 4 (AQP4) antibody has established that NMOSD is indeed a distinct entity . Approximately 80% of patients with NMOSD test positive for aquaporin-4 (AQP4) immunoglobulin G (IgG) antibodies .AQP4-IgG associated NMOSD appears to target astrocytes, not myelin, leading to elevated markers of astrocyte injury during attacks . Untill now there is limited research about understanding the biomarkers of astrocyte injury and the following reactive gliosis. Family with sequence similarity 19-memberA5 (FAM19A5) protein is postulated to regulate nervous and immune cells of the brain as a brain-specific chemokine, but its precise functional role is not well understood . A recent study suggested that FAM19A5 is secreted by reactive astrocytes following CNS damage and triggers reactive gliosis . In another recent study, serum FAM19A5 was higher in patients with NMOSD-AQP4 than in other CNS demyelinating diseases and healthy controls . So, we need to study the level of this novel biomarker among our Egyptian NMOSD patients and whether it shall be a new biomarker for NMOSD .
Moreover just few studies conducted on cognitive dysfunctions in NMOSD patients and they demonstrate a significant decrease of cognitive abilities and the prevalence of CI in different samples varies between 30 and 70% .So further studies are needed to investigate the cognitive performance in NMOSD patients
Read the detailed description
Sixty patients diagnosed as NMOSD based on the recently revised 2015 international consensus diagnostic criteria for NMOSD ,attending Neurology clinic, Asyut University hospitals, Asyut university and Kasr Al-Ainy multiple sclerosis/neuroimmunology clinic, Cairo University hospitals, Cairo University, Egypt, through one and half year from study onset. Sixty healthy volunteers, without any neurological or systemic medical diseases, age and sex matched , will be enrolled as healthy controls(HCs).
Aim of the work :
- Determining the serum level of FAM19A5 in a cohort of Egyptian patients with NMOSD in comparison with healthy controls and its relationship with the different clinical phenotypes and parameters and disease severity of NMOSD patients.
- Cognitive performance of NMOSD patients in comparison with healthy controls.
- Being tested
- serum level of FAM19A5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum level of FAM19A5Diagnostic test
Detection of serum level of FAM19A5 of patients and controls by using ELISA technique.
| Study group | Role | What they receive |
|---|---|---|
| 60 case | Sixty patients diagnosed as NMOSD based on the recently revised 2015 international consensus diagnostic criteria for NMOSD (9) ,attending Neurology clinic, Asyut University hospitals, Asyut university and Kasr Al-Ainy multiple sclerosis/neuroimmunology clinic, Cairo University hospitals, Cairo University, Egypt, through one and half year from study onset Receives: Diagnostic Test: serum level of FAM19A5 | |
| 60 control | Sixty healthy volunteers, without any neurological or systemic medical diseases, age and sex matched , will be enrolled as healthy controls(HCs). Receives: Diagnostic Test: serum level of FAM19A5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the serum level of FAM19A5 in NMOSD bpatients in relation to healthy controls by using ELISA technique
Determining the serum level of FAM19A5 in NMOSD patients in relation to healthy controls by using ELISA technique
Measured: one and half year
Secondary outcomes (1)
Episodic verbal learning and memory of patients and controls will be evaluated by using California verbal learning test second edition
California verbal learning test second edition (CVL ll)of patients and controls The median of each scale will be assessed for patients and age and sex matched healthy controls on the other side and the impairment will be assessed by comparison
Measured: one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Jul 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionApr 2024 (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 Assessment of Serum FAM19A5level in Egyptian Patients With NMOSDStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Khairy Danial, Assiut University
- Investigators
- Hamdy EL tellawy, doctorate, Principal investigator, Assiut UniversityNein Shalaby, doctorate, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446701
- Sponsor's protocol ID
- Serum FAM9A5 in NMOSD patients
- Status last verified
- Jul 2022
- First submitted
- 9 Apr 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meng H, Xu J, Pan C, Cheng J, Hu Y, Hong Y, Shen Y, Dai H. Cognitive dysfunction in adult patients with neuromyelitis optica: a systematic review and meta-analysis. J Neurol. 2017 Aug;264(8):1549-1558. doi: 10.1007/s00415-016-8345-3. Epub 2016 Dec 1.
PubMed 27909800Lee HL, Seok HY, Ryu HW, Cho EB, Kim BC, Kim BJ, Min JH, Seok JM, Shin HY, Kang SY, Kwon OH, Lee SS, Oh J, Sohn EH, Huh SY, Cho JY, Seong JY, Kim BJ. Serum FAM19A5 in neuromyelitis optica spectrum disorders: Can it be a new biomarker representing clinical status? Mult Scler. 2020 Nov;26(13):1700-1707. doi: 10.1177/1352458519885489. Epub 2019 Nov 4.
PubMed 31680620
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Serum FAM19A5 Level in Egyptian Patients With Neuromyelitis Optica Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05446701
- Acronym / sponsor ID
- Serum FAM9A5 in NMOSD patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 7 Jul 2022 (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.
Neuromyelitis optica spectrum disorders (NMOSD) are severe inflammatory autoimmune conditions of the central nervous system (CNS) . The discovery of NMOSD-specific aquaporin 4 (AQP4) antibody has established that NMOSD is indeed a distinct entity . Approximately 80% of patients with NMOSD test positive for aquaporin-4 (AQP4) immunoglobulin G (IgG) antibodies .AQP4-IgG associated NMOSD appears to target astrocytes, not myelin, leading to elevated markers of astrocyte injury during attacks . Untill now there is limited research about understanding the biomarkers of astrocyte injury and the following reactive gliosis. Family with sequence similarity 19-memberA5 (FAM19A5) protein is postulated to regulate nervous and immune cells of the brain as a brain-specific chemokine, but its precise functional role is not well understood . A recent study suggested that FAM19A5 is secreted by reactive astrocytes following CNS damage and triggers reactive gliosis . In another recent study, serum FAM19A5 was higher in patients with NMOSD-AQP4 than in other CNS demyelinating diseases and healthy controls . So, we need to study the level of this novel biomarker among our Egyptian NMOSD patients and whether it shall be a new biomarker for NMOSD .
Moreover just few studies conducted on cognitive dysfunctions in NMOSD patients and they demonstrate a significant decrease of cognitive abilities and the prevalence of CI in different samples varies between 30 and 70% .So further studies are needed to investigate the cognitive performance in NMOSD patients
Detailed description
Sixty patients diagnosed as NMOSD based on the recently revised 2015 international consensus diagnostic criteria for NMOSD ,attending Neurology clinic, Asyut University hospitals, Asyut university and Kasr Al-Ainy multiple sclerosis/neuroimmunology clinic, Cairo University hospitals, Cairo University, Egypt, through one and half year from study onset. Sixty healthy volunteers, without any neurological or systemic medical diseases, age and sex matched , will be enrolled as healthy controls(HCs).
Aim of the work :
- Determining the serum level of FAM19A5 in a cohort of Egyptian patients with NMOSD in comparison with healthy controls and its relationship with the different clinical phenotypes and parameters and disease severity of NMOSD patients.
- Cognitive performance of NMOSD patients in comparison with healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60 case | – | Diagnostic Test: serum level of FAM19A5Sixty patients diagnosed as NMOSD based on the recently revised 2015 international consensus diagnostic criteria for NMOSD (9) ,attending Neurology clinic, Asyut University hospitals, Asyut university and Kasr Al-Ainy multiple sclerosis/neuroimmunology clinic, Cairo University hospitals, Cairo University, Egypt, through one and half year from study onset |
| 60 control | – | Diagnostic Test: serum level of FAM19A5Sixty healthy volunteers, without any neurological or systemic medical diseases, age and sex matched , will be enrolled as healthy controls(HCs). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sixty patients diagnosed as NMOSD based on the recently revised 2015 international consensus diagnostic criteria for NMOSD ,attending Neurology clinic, Asyut University hospitals, Asyut university and Kasr Al-Ainy multiple sclerosis/neuroimmunology clinic, Cairo University hospitals, Cairo University, Egypt, through one and half year from study onset. Sixty healthy volunteers, without any neurological or systemic medical diseases, age and sex matched , will be enrolled as healthy controls(HCs).
Key inclusion criteria (1 listed)
- 1-Both NMOSD AQP-4 +ve and AQP-4 -ve. 2-Age <18 and >60 years. 3-Both males and females. 4-Both receiving or not receiving current immunosuppressants. 5-Any score of extended disability status scale (EDSS).
Key exclusion criteria (3 listed)
- 1-Any neuropsychiatric disorder other than NMOSD such as multiple sclerosis ,CNS infectious diseases or malignancy.
- 2-Systemic conditions influencing analysis of clinical and serological data , such as general infection, malignancy, and hematologic diseases.
- 3-Illiterate patients. 4-History of drug or alcohol abuse
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 |
|---|---|---|
| serum level of FAM19A5Detection of serum level of FAM19A5 of patients and controls by using ELISA technique. | Diagnostic test | 60 case, 60 control |
Primary outcome
Determining the serum level of FAM19A5 in NMOSD bpatients in relation to healthy controls by using ELISA technique
Time frame: one and half year
Determining the serum level of FAM19A5 in NMOSD patients in relation to healthy controls by using ELISA technique
1 secondary outcome
Episodic verbal learning and memory of patients and controls will be evaluated by using California verbal learning test second edition
Time frame: one and half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Background: PubMed 27909800Meng H, Xu J, Pan C, Cheng J, Hu Y, Hong Y, Shen Y, Dai H. Cognitive dysfunction in adult patients with neuromyelitis optica: a systematic review and meta-analysis. J Neurol. 2017 Aug;264(8):1549-1558. doi: 10.1007/s00415-016-8345-3. Epub 2016 Dec 1.
- Background: PubMed 31680620Lee HL, Seok HY, Ryu HW, Cho EB, Kim BC, Kim BJ, Min JH, Seok JM, Shin HY, Kang SY, Kwon OH, Lee SS, Oh J, Sohn EH, Huh SY, Cho JY, Seong JY, Kim BJ. Serum FAM19A5 in neuromyelitis optica spectrum disorders: Can it be a new biomarker representing clinical status? Mult Scler. 2020 Nov;26(13):1700-1707. doi: 10.1177/1352458519885489. Epub 2019 Nov 4.
- Individual participant dataSharing planned: No
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.
Hamdy EL tellawy, doctorate principal investigator
Assiut University
Nein Shalaby, doctorate study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Assessment of Serum FAM19A5level in Egyptian Patients With NMOSD, 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 1 inclusion and 3 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 7 Jul 2022. 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 sarah khairy, master (01023742942, sarahkhairy89@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the serum level of FAM19A5 in NMOSD bpatients in relation to healthy controls by using ELISA technique (time frame: one and half year). 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 NCT05446701, 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 7 Jul 2022.