Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06210464
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-12-18
Brief Title:
Disease and Biomarker Profiling of Chinese Lupus Nephritis
Sponsor:
Nan Shen
Organization:
RenJi Hospital
Study Overview
Official Title:
Disease and Biomarker Profiling of Chinese Lupus Nephritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 7000 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None