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临床试验/NCT06210464
NCT06210464尚未招募不适用

Disease and Biomarker Profiling of Chinese Lupus Nephritis

Nan Shen0 个研究点目标入组 100 人开始时间: 2024年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
Serum SDMA : serum EMIT or LC-MS assayUrinary

研究概览

简要总结

In the proposed study , Novartis Institutes of Biomedical Research ( NIBR ) collaborates with Reni HospitalAffiated to Shanghai Jiaotong University School of Medicine ( Ren ) , aiming to identify particular LNendotype , and to discover novel biomarkers which link the endotype to disease phenotype , especially todisease monitorng , treatment response and prognosis prediction . The study proposes to take bothcandidate approach ( reported biomarkers ) and unbiased high-throughput proteomics profiling tools( Somascan measures up to 7,000 protein analytes ) to analyze 100 Class I / V LN patients with welldocumented clinical annotation , treatment schedule and disease follow up . Both serum / plasma and urrpatients will be extensively characterized with a focus on non-invasive biomarkediscovery and validation . Integrated analysis will be performed to associate patient molecular signature withtheir clinical annotation , renal pathology features , and response to Soc treatment . We will generahypothesis from these analyses to propose molecular markers to predict patient response to Soc treatmentand to endotype the disease , discover the mechanisms that could contrbute to unsatisfactory response toSoc , and identity more specific and sensitive non-invasive biomarkers in serum or urine that can be used in disease monitoring , disease prognosis and patient stratificationproposed study Will help usunderstand the heterogeneity of LN at the molecular level , which could be an essential first step towardsLN precision medicine . It will provide scientific rationale for improved LN clinical diagnosis , novel therapeutichypothesis , patient stratification , clinical study design and combination strategy.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to communicate well with investigator, understand the study procedures and provide writteninformed consent before any study-related sample/data are accesse
  • Men and women with systemic lupus erythematosus (see below), aged 18 years and 75 years fulfilling 1997 ACR classification criteria for SLE, or 2012 SLICC classification criteria for SLE,OI2020 eularacr classification criteria for sstological diagnosis of proliferative lupusnephritis wealth OrganizationO)ISN/RPS (Weening et al 2004) Class I or class IV,with soc treatment anddisease monitoringleast one year
  • Serum/plasma and urine samples were collected at baseline of the treatme

排除标准

  • 1.Presence of another autoimmune rheumatic disease that is active and constitutes the principalIllness , except for rheumatoid arthritis , Sjogrens syndrome and autoimmune thyroiditis 2 . Any glomerulonephritis other than WHO Class l or V lupus nephritis Patients with proliferativenephritis ( Class l or V ) who , in addition , have overlapping histological signs for other glomerulonephritis , e.g. , Class V are eligible at the investigator s discretion
  • History of malignancy with the exception of basal cell or squamous cell carcinoma of the skin orsitu carcinoma of the cervix within the last 2 vears 4 . Urinary system infection 5 . Pregnant women

结局指标

主要结局

Serum SDMA : serum EMIT or LC-MS assayUrinary

时间窗: 2025

SCD163 : urine ELISA assay

时间窗: 2025

Urine RALL Index ( NGAL , KIM-1 , MCP-1 , Adiponectin , Ceruloplasmin andHemopexin ) 4-plex panel ELLA and two single-plex ELISA

时间窗: 2025

Urine Creatinine urine BM data normalization , enzymatic method on Cobas

时间窗: 2025

次要结局

未报告次要终点

研究者

发起方
Nan Shen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nan Shen

Chief physician

RenJi Hospital

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