Epigenetics in Lupus Nephritis

NCT04648059 | Unknown

• 1 other identifier: 28/9/17
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a translational study for the identification of epigenetic changes detectable in sera of patients suffering from Systemic Lupus erythematosus. The aim of the study is to analyze whether circulating DNA fragments are 1) different in patients with or without Lupus nephritis and 2) present and detectable in the circulation before the development of Lupus nephritis.

Conditions

Systemic Lupus Erythematosus; Lupus Nephritis

Keywords

Epigenetics; Methylation; Toll-like receptors; Fibrosis

Outcome Measures

Primary Outcomes (1)

• Methylated CpG-rich DNA fragments

  it will be analyzed whether circulating CpG-rich DNA fragments are present in patients' blood

  12 months

Study Arms (2)

Lupus nephritis +ve

This group consists of patients with Lupus nephritis

Diagnostic Test: Blood sampling

Lupus nephritis -ve

This group consist of patients with SLE without Lupus nephritis

Diagnostic Test: Blood sampling

Interventions

Blood sampling DIAGNOSTIC_TEST

Blood sampling will be performed to allow analyses of epigenetic markers

Lupus nephritis +ve; Lupus nephritis -ve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of a sample of patients with systemic lupus nephritis (SLE). There will be analyses for the presence of epigenetic markers (methylated CpG-rich DNA fragments) between two groups: 1) patients with SLE with Lupus nephritis (LN) and 2) patients with SLE without LN. In the first phase of the study, a cross-sectional sample of patients will be analyzed. In the second phase of the study, patient samples will be prospectively analyzed for the presence of these markers.

You may qualify if:

• Diagnosis of systemic lupus erythematosus according to the current classification criteria
• a subgroup requires the presence of Lupus nephritis (no restriction to specific LN histologic subtypes)

You may not qualify if:

• patients not able or unwilling to provide written informed consent

Sponsors & Collaborators

• University of Göttingen: lead
• King's College London: collaborator
• Università degli Studi di Brescia: collaborator

Study Sites (1)

University Medical Center Göttingen

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Circulating CpG-rich DNA fragments

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis; Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

PETER KORSTEN, MD

CONTACT

055139; peter.korsten@med.uni-goettingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: March 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)