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

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ClinicalTrials.gov Identifier: NCT03687138
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
cic bioGune
Information provided by (Responsible Party):
Natalia A. Rivera García, Hospital de Basurto

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.


Condition or disease Intervention/treatment
Lupus Nephritis Lupus Erythematosus, Systemic Other: 24h urin sample

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Searching for Diagnostic/Prognostic Biomarkers in Systemic Lupus Erythematosus (SLE) With Renal Involvement by Proteomic Techniques. A Multicentre Study
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Group/Cohort Intervention/treatment
Control 1
This is the control population. The analysis will be done with a 24h urin sample. We will compare this population with the other two.
Other: 24h urin sample
The samples will analyzed by proteomic techniques

Control 2
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
The samples will analyzed by proteomic techniques

Study population
This is the study population. The analysis will be done with a 24h urin sample. We will compare this population with the other two controls populations.
Other: 24h urin sample
The samples will analyzed by proteomic techniques




Primary Outcome Measures :
  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 [ Time Frame: 3 year ]
    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.


Biospecimen Retention:   Samples Without DNA
24-hour urine sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Criteria

Inclusion Criteria:

  1. Healthy comparison group (controls)

    1. People aged 18 years old and over
    2. Negative results in serological tests for hepatitis B and C and HIV
    3. No known autoimmune diseases when samples were taken
    4. Matched to a patient by age, plus or minus 5 years
    5. Willing and able to give informed consent to their participation in the study
  2. First comparison group of patients

    1. The same characteristics as the control group regarding points a, b, d, and e
    2. Diagnosed with SLE, according to the ACR criteria (meeting 4 out of the 11 criteria)
    3. No known renal involvement

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687138


Contacts
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Contact: Natalia A. Rivera García, PhD 660930837 NATALIAANDREA.RIVERAGARCIA@osakidetza.eus

Locations
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Spain
Basurto University Hospital Recruiting
Bilbao, Bizkaia, Spain, 48013
Contact: Natalia A. R Rivera García, PhD    660930837    NATALIAANDREA.RIVERAGARCIA@osakidetza.eus   
Sponsors and Collaborators
Natalia A. Rivera García
cic bioGune

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Responsible Party: Natalia A. Rivera García, Biology PhD, Hospital de Basurto
ClinicalTrials.gov Identifier: NCT03687138     History of Changes
Other Study ID Numbers: EstMcBasNL_001
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Nephritis
Lupus Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Glomerulonephritis