NCT07653984 Cohort Study on Neuroimmune Diseases in the Reproductive Age
| NCT ID | NCT07653984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University |
| Condition | Neuromyelitis Optica Spectrum Disorders (NMOSD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-21 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-04-21 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Neuroimmune diseases are more prevalent among women of reproductive age. Studies have shown that neuroimmune diseases may impact fertility. Therefore, effective management of neuroimmune diseases during pregnancy is particularly important. This study included a follow-up period of up to five years in patients with pregnancy-associated neuroimmune disorders. Data collected included relapse frequency, symptomatology, imaging findings, treatment regimens, peripheral blood profiles, EDSS scores, and MRI results. In addition, maternal drug concentrations, postpartum relapse rates, and neonatal development were monitored after delivery. Following the successful completion of the five-year follow-up, the research team plans to continue the prospective epidemiological study with ten-year follow-up phases. The aim of this study is to generate detailed clinical data on pregnancy-associated autoimmune diseases and to equip clinicians with evidence-based strategies for optimizing disease management during the reproductive age.
Eligibility Criteria
Inclusion Criteria: * Patient Group: A total of fifty participants are expected to be enrolled. 1. Women aged 20-55 years with childbearing potential. 2. Voluntary informed consent. 3. Availability of complete personal information. 4. A confirmed diagnosis of neuromyelitis optica spectrum disorder (NMOSD), multiple sclerosis (MS), autoimmune encephalitis, myasthenia gravis, Guillain-Barré syndrome, or myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). Healthy Control Group: A total of fifty healthy women are expected to be included. 1. Age- and sex-matched women of childbearing age with plans for pregnancy 2. Voluntary informed consent. 3. Availability of complete personal information. Exclusion Criteria: * Patient Group: 1. Patients with an undetermined or unconfirmed diagnosis. 2. Incomplete personal information that cannot be obtained through follow-up. 3. Participants who voluntarily withdrew from the study and revoked informed consent. Healthy Control Group: 1. Individuals diagnosed with neuroimmune-related disorders. 2. Incomplete personal information that cannot be obtained through follow-up. 3. Participants who voluntarily withdrew from the study and revoked informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07653984 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 55 Years, studying Neuromyelitis Optica Spectrum Disorders (NMOSD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07653984 currently recruiting?
Yes, NCT07653984 is actively recruiting participants. Contact the research team at qiuwei120@vip.163.com for enrollment information.
Where is the NCT07653984 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07653984 clinical trial?
NCT07653984 is sponsored by Third Affiliated Hospital, Sun Yat-Sen University. The trial plans to enroll 100 participants.