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Recruiting NCT07043153

AGR+PNI as Predictors of Systemic Lupus Erythematosus Disease Activity

— Observational Systemic Lupus Erythematosus Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Albumin to globulin ratio and prognostic nutritional index model.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Using Combination of Albumin to Globulin Ratio and Prognostic Nutritional Index Model for Predicting Disease Activity in Patients With Systemic Lupus Erythematosus

Overview

This study aims to evaluate the clinical utility of combining the albumin to globulin ratio (AGR) and the prognostic nutritional index (PNI) as a predictive model for assessing disease activity in patients with systemic lupus erythematosus (SLE). By correlating these nutritional and inflammatory markers with clinical manifestations and laboratory parameters, we hope to establish a simple, non-invasive, and cost-effective tool to aid in monitoring disease activity in Systemic lupus erythematosus patients.

Interventions

  • Diagnostic test Albumin to globulin ratio and prognostic nutritional index model
    Measurement of albumin to globulin ratio and prognostic nutritional index in participants to assess disease activity in systemic lupus erythematosus patients

Primary outcome measures

  • assess the utility of the albumin-to-globulin ratio (AGR) as reliable, non-invasive biomarker for predicting disease activity in patients with systemic lupus erythematosus (SLE). [Time frame: From 6 month to one year]

Eligibility criteria

Inclusion criteria

  • · Age ≥ 18 years.
  • Both sexes.
  • Patients diagnosed with SLE who fulfilling the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria and matched controls.

Exclusion criteria

  • Co-existing chronic inflammatory or autoimmune diseases.
  • Age <18 years
  • Malignancy.
  • Pregnancy or lactation.
  • Chronic liver or renal insufficiency.
  • Malignant hematologic diseases.
  • Active hepatitis.
  • Acute infection within the previous four weeks

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

Egypt · 1 center
  • Sohag University hospitals — Sohag

Publications

  • Idborg H, Eketjall S, Pettersson S, Gustafsson JT, Zickert A, Kvarnstrom M, Oke V, Jakobsson PJ, Gunnarsson I, Svenungsson E. TNF-alpha and plasma albumin as biomarkers of disease activity in systemic lupus erythematosus. Lupus Sci Med. 2018 Jun 4;5(1):e000260. doi: 10.1136/lupus-2018-000260. eCollection 2018. PMID 29955370
  • Guo X, Shao J, Zhai B, Zou Q, Yan J, Gu H, Wang G. Relationship and prognostic significance between preoperative serum albumin to globulin ratio and CT features of non-small cell lung cancer. Eur J Radiol. 2020 Jul;128:109039. doi: 10.1016/j.ejrad.2020.109039. Epub 2020 May 4. PMID 32417713
  • Barber MRW, Drenkard C, Falasinnu T, Hoi A, Mak A, Kow NY, Svenungsson E, Peterson J, Clarke AE, Ramsey-Goldman R. Global epidemiology of systemic lupus erythematosus. Nat Rev Rheumatol. 2021 Sep;17(9):515-532. doi: 10.1038/s41584-021-00668-1. Epub 2021 Aug 3. PMID 34345022
  • Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, PMID 31383717

Identifiers

NCT: NCT07043153 · Soh-Med--25-6-1MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗