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Disease and Biomarker Profiling of Chinese Lupus Nephritis

NCT06210464 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-01-18

No results posted yet for this study

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 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.

Conditions

  • Characterize the Molecular Profile of Lupus Nephritis(LN) Patients to Understand Themechanism(s)Contributing to Patient Responsiveness to Soc
  • Integrated Analysis of LN Patient Molecular Profiling and Clinical Annotations to Understand LNdisease Heterogeneity for Disease Endotype
  • Validate the Association of the Candidate Biomarker Panel Proposed in Table 3-1 With LN Diseasemonitoring

Interventions

OTHER

Trial have no Intervention measures.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Nan Shen

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2025-03-01
Completion
2025-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06210464 on ClinicalTrials.gov