Lupus Erythematosus, SystemicNCT05607368
Mast Cells Are Involved in the Mechanism of NPSLE Epilepsy
An observational study of Lupus Erythematosus, Systemic, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Tryptase, TLR4, and anti-NR2A antibodies were measured in serum, cerebrospinal fluid, and subjects and other markers to assess their relevance to disease activity, aiming to find new therapeutic targets,Timely intervention to improve the prognosis of SLE and improve the quality of life of patients with SLE. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lupus Erythematosus, Systemic
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Nanfang Hospital presents patients with systemic lupus erythematosus (SLE) and neuropsychiatric lupus(NPSLE) patients with epilepsy, as well as health examinations at the Health Management Center of Southern Hospital Healthy subjects
Who may be able to join
- Healthy control group
- Voluntary signing of informed consent;
- Healthy volunteers older than 18 years old and less than 50 years old, regardless of gender;
- No systemic diseases or neurological symptoms or signs;
- According to the judge's judgment, healthy volunteers matching the NPSLE epilepsy group in terms of gender, age, and education level were selected as the control group.
- SLE group
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- Voluntary signing of informed consent;
- Age greater than 18 years old, less than 50 years old, gender is not limited;
- Patients with SLE who meet diagnostic criteria.
- NPSLE Epilepsy Group
- Voluntary signing of informed consent;
- Age greater than 18 years old, less than 50 years old, gender is not limited;
- Patients with NPSLE epilepsy who meet diagnostic criteria.
Who cannot join
- SLE group
- patients with SLE with other autoimmune diseases;
- Previous seizures, psychiatric abnormalities and other manifestations;
- MR of the head has obvious abnormal signals in the skull or EEG shows abnormal signals;
- History of use of hormones and immunosuppressants;
- The investigators judged that it was not suitable to participate in this study.
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- NPSLE Epilepsy Group
- prior history of epilepsy or clear cranial MR findings suggesting structural abnormalities;
- Presence of precipitating seizures such as sleep deprivation, high fever, infection, long-term abstinence from alcoholism
- Interrupt, patients with systemic diseases such as hypoglycemia, severe electrolyte disorders, malignant lesions, progressive or degenerative diseases, severe liver and kidney insufficiency and other metabolic diseases;
- The investigators judged that it was not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qin Huang
Guangzhou, Guangdong, 510515
Qin Huang, 13632430850, qinzihq@foxmail.com
About this study
Tryptase, TLR4, and anti-NR2A antibodies were measured in serum, cerebrospinal fluid, and subjects and other markers to assess their relevance to disease activity, aiming to find new therapeutic targets,Timely intervention to improve the prognosis of SLE and improve the quality of life of patients with SLE.
Read the detailed description
This study is a prospective cohort study: it is proposed to be divided into 3 groups, namely healthy control group and SLE group, NPSLE epilepsy group; Fifteen cases were included in each group, with the consent of the subjects and signed to know Consent form, record all subjects' clinical and laboratory test data, and test subjects' blood. Markers such as cerebrospinal fluid tryptase, TLR4 and anti-NR2A antibodies, follow-up 2 year, the patient's disease activity is evaluated every year, the change of indicators is dynamically observed, and statistical points are made divide.
- Conditions
- Lupus Erythematosus, Systemic
- Medical subject headings
- Lupus Erythematosus, Systemic
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 |
|---|---|---|
| SLE group | 1. Voluntary signing of informed consent; 2. Age greater than 18 years old, less than 50 years old, gender is not limited; 3. Patients with SLE who meet diagnostic criteria. | |
| NPSLE epilepsy group | 1. Voluntary signing of informed consent. 2. Age greater than 18 years old, less than 50 years old, gender is not limited. 3. Patients with NPSLE epilepsy who meet diagnostic criteria. | |
| Healthy control group | 1. Voluntary signing of informed consent; 2. Healthy volunteers older than 18 years old and less than 50 years old, regardless of gender; 3. No systemic diseases and neurological symptoms and signs; 4. According to the judge's judgment, healthy volunteers matching the NPSLE epilepsy group in terms of gender, age, and education level were selected as the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in disease activity index
SLEDAI
Measured: Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24
Numerical changes in markers such as tryptase, TLR4, and anti-NR2A antibodies in blood and cerebrospinal fluid
Measured: Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HUNAG QIN, Nanfang Hospital, Southern Medical University
- Investigators
- Qin Huang, Doctor, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607368
- Sponsor's protocol ID
- NFEC-2022-005
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mast Cells Are Involved in the Mechanism of NPSLE Epilepsy
- ClinicalTrials.gov ID
- NCT05607368
- Acronym / sponsor ID
- NFEC-2022-005
- Conditions
- Lupus Erythematosus, Systemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Nov 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.
Tryptase, TLR4, and anti-NR2A antibodies were measured in serum, cerebrospinal fluid, and subjects and other markers to assess their relevance to disease activity, aiming to find new therapeutic targets,Timely intervention to improve the prognosis of SLE and improve the quality of life of patients with SLE.
Detailed description
This study is a prospective cohort study: it is proposed to be divided into 3 groups, namely healthy control group and SLE group, NPSLE epilepsy group; Fifteen cases were included in each group, with the consent of the subjects and signed to know Consent form, record all subjects' clinical and laboratory test data, and test subjects' blood. Markers such as cerebrospinal fluid tryptase, TLR4 and anti-NR2A antibodies, follow-up 2 year, the patient's disease activity is evaluated every year, the change of indicators is dynamically observed, and statistical points are made divide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLE group | – | –1. Voluntary signing of informed consent; 2. Age greater than 18 years old, less than 50 years old, gender is not limited; 3. Patients with SLE who meet diagnostic criteria. |
| NPSLE epilepsy group | – | –1. Voluntary signing of informed consent. 2. Age greater than 18 years old, less than 50 years old, gender is not limited. 3. Patients with NPSLE epilepsy who meet diagnostic criteria. |
| Healthy control group | – | –1. Voluntary signing of informed consent; 2. Healthy volunteers older than 18 years old and less than 50 years old, regardless of gender; 3. No systemic diseases and neurological symptoms and signs; 4. According to the judge's judgment, healthy volunteers matching the NPSLE epilepsy group in terms of gender, age, and education level were selected as the control group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Nanfang Hospital presents patients with systemic lupus erythematosus (SLE) and neuropsychiatric lupus(NPSLE) patients with epilepsy, as well as health examinations at the Health Management Center of Southern Hospital Healthy subjects
Key inclusion criteria (13 listed)
- Healthy control group
- SLE group
- NPSLE Epilepsy Group
Key exclusion criteria (11 listed)
- SLE group
- NPSLE Epilepsy Group
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
Changes in disease activity index
Time frame: Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24
SLEDAI
Numerical changes in markers such as tryptase, TLR4, and anti-NR2A antibodies in blood and cerebrospinal fluid
Time frame: Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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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.
Qin Huang, Doctor principal investigator
Southern Medical University, China
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 Lupus Erythematosus, Systemic, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 13 inclusion and 11 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 Nov 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Huang, Doctor (13632430850, qinzihq@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in disease activity index (time frame: Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24). 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?
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 Nov 2022.