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出境医 / 临床实验 / Immune Profile of Acute VKH Patients PBMC (IPV)
Immune Profile of Acute VKH Patients PBMC (IPV)
Study Description
Brief Summary:
The investigators will collect blood samples of different courses of VKH patients for investigating immune profile, observe major immune cells number ,functional and membrane molecular changes in the course of treatment, to investigate pathogenesis of VKH. Meanwhile, the investigators will collect clinical data of VKH patients to observe choroid and retina change in different courses.
| Condition or disease | Intervention/treatment |
|---|---|
| VKH Syndrome | Drug: Steroids |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 48 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Clinical Observational Research on Changes of Peripheral Blood Mononuclear Cell（PBMC） Immunity and Expression Profile in Peripheral Blood of Different Course of of Vogt-Hoyanagi-Harada（VKH） Patients. |
| Estimated Study Start Date : | July 20, 2019 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | July 7, 2022 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
VKH patients
acute VKH patients
|
Drug: Steroids
IV and oral steroids
|
|
control
health people age/sex match to the VKH patients
|
Outcome Measures
Primary Outcome Measures :
- T/B /NK(natural killer )/monocyte...etc, cell numbers of blood samples in VKH patients [ Time Frame: one year ]use flow cytometry to count T/B /NK/monocyte...etc, cell numbers
- T/B /NK/monocyte...etc cell subtype proportion in blood samples in VKH patients [ Time Frame: one year ]use flow cytometry to measure T/B /NK/monocyte...etc cell subtype proportion
- T/B /NK/monocyte...etc cell functional change in VKH patients [ Time Frame: one year ]use ELISA(enzyme linked immunosorbent assay) to measure inflammatory cytokines level in peripheral blood
Secondary Outcome Measures :
- choroid and retinal thickness change in different course of VKH patients [ Time Frame: one year ]Use OCT（optical coherence tomography） to measure choroid and retina thickness changes in macular zone of different course VKH patients
- Use OCTA(optical coherence tomography angiography) to measure macular and optic disc vascular index [ Time Frame: one year ]Use OCTA to measure macular and optic disc vascular index in different course VKH patients
- Use Maia perimeter to measure macular integrality [ Time Frame: one year ]Use Maia perimeter to measure macular integrality including light threshold and central fixation.
- measure the Injury degree of choroid and retinal vessels [ Time Frame: one year ]Use FFA(fluorescein fundus angiography)/ICG(Indocyanine Green Angiography) to measure the Injury degree of choroid and retinal vessels
Biospecimen Retention: Samples With DNA
blood sample of VKH patients
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
acute primary VKH patients
Criteria
Inclusion Criteria:
- Acute VKH patients, meet a criterion of VKH, no recurrence.
- Age range from 18 to 50 years old.
Exclusion Criteria:
- Patients with Severe Cardiovascular and Cerebrovascular Diseases
- Patients allergic to steroid or contrast agents;
- A history of ocular trauma or intraocular surgery within 3 months; Vaccinated; History of infectious diseases
- having a history of heredity, immune system correlation, neuroendocrine and digestive system diseases
- Patients who take health care products for a long time and have heavy alcohol and tobacco addiction.
Contacts and Locations
Contacts
| Contact: Zhaohui Li, Ph.D/MD | +86-186-2790-1441 | lizhaohui@whu.edu.cn | |
| Contact: Yafei Huang, Ph.d | +86-136-2862-7928 | huangyf@tjh.tjmu.edu.cn |
Locations
| China, Hubei | |
| Wuhan Aier eye hospital | Recruiting |
| Wuhan, Hubei, China, 430064 | |
| Contact: Zhaohui Li, Ph.D/MD +86-186-2790-1441 lizhaohui@whu.edu.cn | |
| Contact: Yafei Huang, Ph.D +86-136-28627928 huangyf@tjh.tjmu.edu.cn | |
Sponsors and Collaborators
Aier School of Ophthalmology, Central South University
Investigators
| Study Director: | Qing Zhang, MD | Central-southern university, Aier ophthalmology colleage |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 14, 2019 | ||||||||
| First Posted Date | July 19, 2019 | ||||||||
| Last Update Posted Date | July 22, 2019 | ||||||||
| Estimated Study Start Date | July 20, 2019 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Immune Profile of Acute VKH Patients PBMC | ||||||||
| Official Title | Clinical Observational Research on Changes of Peripheral Blood Mononuclear Cell（PBMC） Immunity and Expression Profile in Peripheral Blood of Different Course of of Vogt-Hoyanagi-Harada（VKH） Patients. | ||||||||
| Brief Summary | The investigators will collect blood samples of different courses of VKH patients for investigating immune profile, observe major immune cells number ,functional and membrane molecular changes in the course of treatment, to investigate pathogenesis of VKH. Meanwhile, the investigators will collect clinical data of VKH patients to observe choroid and retina change in different courses. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
blood sample of VKH patients
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | acute primary VKH patients | ||||||||
| Condition | VKH Syndrome | ||||||||
| Intervention | Drug: Steroids
IV and oral steroids
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
48 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | July 7, 2022 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
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| Ages | 18 Years to 50 Years (Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
|
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04025476 | ||||||||
| Other Study ID Numbers | AFM1713D1 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
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| Responsible Party | Aier School of Ophthalmology, Central South University | ||||||||
| Study Sponsor | Aier School of Ophthalmology, Central South University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
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| PRS Account | Aier School of Ophthalmology, Central South University | ||||||||
| Verification Date | July 2019 | ||||||||
