Searching for Diagnostic/Prognostic Biomarkers in SLE With Renal Involvement by Proteomic Techniques

NCT03687138 | Completed DMC

• 1 other identifier: EstMcBasNL_001
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To search for potential biomarkers obtained by non-invasive methods (24-hour urine collection) that distinguish between patients diagnosed with systemic lupus erythematosus with or without renal involvement, patients with non-autoimmune renal disease and healthy donors. Lupus nephritis is one of the most common and severe complications of systemic lupus erythematosus, causing from asymptomatic mild proteinuria to rapidly progressive glomerulonephritis with kidney failure. To date, kidney biopsy (an invasive medical procedure with associated risks and complications) is essential for making a definitive diagnosis, assessing the severity of the damage and deciding on the best treatment. In relation to this, the identification of biomarkers using a non-invasive biological sample could help to classify population groups, and this would be a great step forward in the clinical setting. In this research project, we propose to conduct a case and control study. For this, we will first carefully classify the study groups, using clinical data on patients and by testing a pool of peptides described in the scientific literature in each of the sample groups, using solid phase extraction combined with matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. Subsequently, we will carry out multivariate principal component analysis on the data collected, and calculate corresponding receiver operating characteristic curves, to enable us to identify the masses corresponding to peptides with potential as biomarkers. We will then use classification algorithms to select sets of masses that would allow us to distinguish the population groups, and generate statistical classifiers for assessing the level of confidence in the model and its subsequent validation.

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

• Number of specific endogenous peptides of each study population to help us differentiate among these by solid phase extraction and mass spectrometry that will be applied to urine samples

  Solid phase extraction and mass spectrometry will be applied to urine samples to get information about endogenous peptides that will allow the differentiation among above described populations (SLE patients, patients without NL with no autoimmune nephropathy and healthy donors). This may have a direct impact in future early diagnosis, facilitating clinicians to apply a better and more effective treatment.

  3 year

Study Arms (2)

Control 1

This is the control LES population. The analysis will be done with a 24h urin sample. We will compare this population with the other control population and the study population.

Other: 24h urin sample

Study population

This is the study population. The analysis will be done with a 24h urin sample. We will compare this population with the controls populations.

Other: 24h urin sample

Interventions

24h urin sample OTHER

The samples will analyzed by proteomic techniques

Control 1; Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is to be adult patients diagnosed with SLE, following the criteria of the American College of Rheumatology (ACR), that is, individuals who meet at least 4 of the 11 classification criteria; and who have class III, IV, V or VI LN according to the International Society of Nephrology (ISN)/Renal Pathology Society (RPS) 2003 classification, confirmed by kidney biopsy, or active disease activity according to the British Isles Lupus Assessment Group (BILAG) index (Hay E et al., 1993).

You may qualify if:

• Healthy comparison group (controls)
• People aged 18 years old and over
• Negative results in serological tests for hepatitis B and C and HIV
• No known autoimmune diseases when samples were taken
• Matched to a patient by age, plus or minus 5 years
• Willing and able to give informed consent to their participation in the study
• First comparison group of patients
• The same characteristics as the control group regarding points a, b, d, and e
• Diagnosed with SLE, according to the ACR criteria (meeting 4 out of the 11 criteria)
• No known renal involvement

You may not qualify if:

• People aged under 18 years old
• Positive results in serological tests for hepatitis B and C and HIV
• Not to give informed consent to their participation in the study

Sponsors & Collaborators

• Natalia A. Rivera García: lead
• cic bioGune: collaborator

Study Sites (1)

Basurto University Hospital

Bilbao, Bizkaia, 48013, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

24-hour urine sample

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Biology PhD

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 27, 2018
• Study Start: June 15, 2018
• Primary Completion: March 31, 2020
• Study Completion: February 28, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)