Screening Biomarkers for Severe Lupus Based on Multi-omics Studies

NCT05539001 | Unknown

• 1 other identifier: 2022-LCYJ-MS-04
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

In order to achieve accurate diagnosis and treatment of the disease, we performed RNA sequencing and ATAC(Assay for Transposase Accessible Chromatin) chromatin open sequencing in lupus patients in the early stage. By comparing with normal controls, other rheumatic immune diseases (rheumatoid arthritis), and before and after treatment, dozens of disease-causing genes independently associated with the disease were identified. Based on the previous omics results, this project will analyze its changes in different outcomes of lupus patients, and use machine learning methods to establish an optimal severe prediction model, so as to build an early diagnosis system based on novel biomarkers and reduce all-cause mortality in patients with treatment failure rate. It is expected to produce good social and economic benefits.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• The severity of lupus

  Using the British Isles Lupus Assessment Group (BILAG) to judge severe lupus

  12 months after enrollment

Study Arms (1)

systemic lupus erythematosus group

Based on hospitalization and follow-up data, the enrolled patients were divided into severe group and mild group by BILAG score independently by specialized researchers.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Inpatients in the Department of Rheumatology and Immunology, Drum Tower Hospital Affiliated to Nanjing University School of Medicine were recruited

You may qualify if:

• Meet at least 4 of the 11 systemic lupus erythematosus(SLE) classification criteria established by the American College of Rheumatology (ACR) in 1997;
• The age range is 18-60 years;
• Sign the informed consent and be willing to provide blood samples

You may not qualify if:

• Have other autoimmune diseases other than SLE: including dermatomyositis/polymyositis, mixed connective tissue disease, systemic sclerosis, rheumatoid arthritis, etc., but not including secondary Sjogren's syndrome symptomatic patients.
• Those with organ failure; or those with an estimated survival period of less than 4 weeks;
• Combined with various infections (at least one blood or secretion culture result is positive, or at least one second-generation sequencing detects the pathogen sequence and conforms to clinical manifestations, or is clinically judged by a physician as infection);
• Combined pregnancy.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, China

RECRUITING

Related Publications (8)

• Feng X, Pan W, Liu L, Wu M, Ding F, Hu H, Ding X, Wei H, Zou Y, Qian X, Wang M, Wu J, Tao J, Tan J, Da Z, Zhang M, Li J, Sun L; Jiangsu Lupus Collaborative Group. Prognosis for Hospitalized Patients with Systemic Lupus Erythematosus in China: 5-Year Update of the Jiangsu Cohort. PLoS One. 2016 Dec 28;11(12):e0168619. doi: 10.1371/journal.pone.0168619. eCollection 2016.

  PMID: 28030595 BACKGROUND

• Li Z, Wu X, Leo PJ, De Guzman E, Akkoc N, Breban M, Macfarlane GJ, Mahmoudi M, Marzo-Ortega H, Anderson LK, Wheeler L, Chou CT, Harrison AA, Stebbings S, Jones GT, Bang SY, Wang G, Jamshidi A, Farhadi E, Song J, Lin L, Li M, Wei JC, Martin NG, Wright MJ, Lee M, Wang Y, Zhan J, Zhang JS, Wang X, Jin ZB, Weisman MH, Gensler LS, Ward MM, Rahbar MH, Diekman L, Kim TH, Reveille JD, Wordsworth BP, Xu H, Brown MA; TCRI AS Group. Polygenic Risk Scores have high diagnostic capacity in ankylosing spondylitis. Ann Rheum Dis. 2021 Sep;80(9):1168-1174. doi: 10.1136/annrheumdis-2020-219446. Epub 2021 Apr 20.

  PMID: 34161253 BACKGROUND

• Fanouriakis A, Kostopoulou M, Alunno A, Aringer M, Bajema I, Boletis JN, Cervera R, Doria A, Gordon C, Govoni M, Houssiau F, Jayne D, Kouloumas M, Kuhn A, Larsen JL, Lerstrom K, Moroni G, Mosca M, Schneider M, Smolen JS, Svenungsson E, Tesar V, Tincani A, Troldborg A, van Vollenhoven R, Wenzel J, Bertsias G, Boumpas DT. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis. 2019 Jun;78(6):736-745. doi: 10.1136/annrheumdis-2019-215089. Epub 2019 Mar 29.

  PMID: 30926722 BACKGROUND

• Isenberg DA, Rahman A, Allen E, Farewell V, Akil M, Bruce IN, D'Cruz D, Griffiths B, Khamashta M, Maddison P, McHugh N, Snaith M, Teh LS, Yee CS, Zoma A, Gordon C. BILAG 2004. Development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus. Rheumatology (Oxford). 2005 Jul;44(7):902-6. doi: 10.1093/rheumatology/keh624. Epub 2005 Apr 6.

  PMID: 15814577 BACKGROUND

• Feng X, Zou Y, Pan W, Wang X, Wu M, Zhang M, Tao J, Zhang Y, Tan K, Li J, Chen Z, Ding X, Qian X, Da Z, Wang M, Sun L. Prognostic indicators of hospitalized patients with systemic lupus erythematosus: a large retrospective multicenter study in China. J Rheumatol. 2011 Jul;38(7):1289-95. doi: 10.3899/jrheum.101088. Epub 2011 Apr 1.

  PMID: 21459949 BACKGROUND

• Li K, Mo W, Wu L, Wu X, Luo C, Xiao X, Jia X, Yang H, Fei Y, Chen H, Zhang F, Li Y, Zhao L, Zhang X. Novel autoantibodies identified in ACPA-negative rheumatoid arthritis. Ann Rheum Dis. 2021 Jun;80(6):739-747. doi: 10.1136/annrheumdis-2020-218460. Epub 2021 Jan 15.

  PMID: 33452006 BACKGROUND

• Zhu Y, Tang X, Xu Y, Wu S, Liu W, Geng L, Ma X, Tsao BP, Feng X, Sun L. RNASE2 Mediates Age-Associated B Cell Expansion Through Monocyte Derived IL-10 in Patients With Systemic Lupus Erythematosus. Front Immunol. 2022 Feb 21;13:752189. doi: 10.3389/fimmu.2022.752189. eCollection 2022.

  PMID: 35265065 BACKGROUND

• Chen W, Li W, Zhang Z, Tang X, Wu S, Yao G, Li K, Wang D, Xu Y, Feng R, Duan X, Fan X, Lu L, Chen W, Li C, Sun L. Lipocalin-2 Exacerbates Lupus Nephritis by Promoting Th1 Cell Differentiation. J Am Soc Nephrol. 2020 Oct;31(10):2263-2277. doi: 10.1681/ASN.2019090937. Epub 2020 Jul 9.

  PMID: 32646856 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• xuebing Feng, director

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY DIRECTOR

Central Study Contacts

xuebing Feng, director

CONTACT

18805195759; zjj18805195759@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 14, 2022
• Study Start: February 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: June 30, 2025
• Last Updated: April 19, 2023

Record last verified: 2022-09

Locations

CN (1)