Pilotstudy about the role of regulatory immune cells in autoimmunity, cancer and organ rejection after kidney transplantatio

• Conditions: E10; M06; M32; M34; C18; Z94.0; Type 1 diabetes mellitus; Other rheumatoid arthritis; Systemic lupus erythematosus; Systemic sclerosis

• Registration Number: DRKS00026238
• Lead Sponsor: Medizinische Universität Graz, Department für Innere Medizin, Abteilung für Endokrinologie und Diabetologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-04-28
• Study Start: 2021-09-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 485

Inclusion Criteria

Group 1: Healthy participants: healthy participants with no history of autoimmune diseases, transplantation or cancer diseases / Group 2: Type 1 Diabetes Mellitus patients: Manifested type 1 diabetes mellitus as defined by treating physicians / Group 3: Rheumatoid Arthritis patients: Manifested rheumatoid arthritis as defined by 2010 ACR/EUCLAR criteria / Group 4: Systemic Lupus erythematodes patients: Manifested systemic lupus erythematodes as defined by the 2012 SLICC crietria / Group 5: Systemic sclerosis patients: Manifested systemic slcerosis as defined by the EULAR/ACR 2013 classification criteria / Group 6: Cancer patients: Histologically confirmed colo-rectal cancer / Group 7: Kidney transplant recipients: Patients who received a first kidney transplantation

Exclusion Criteria

Exclusion criteria for all patients involved in this study: pregnancy; acute or chronic infection / Exclusion criteria per defined study-subgroup:
Group 1: Healthy participants: any history of autoimmune diseases, transplantation or cancer diseases; glucocorticoid or immunosuppressive therapy within the last 3 months; manifest Type 2 diabetes mellitus / Group 2: Type 1 Diabetes Mellitus patients: glucocorticoid or immunosuppressive therapy within the last 3 months; neoplastic diseases / Group 3: Rheumatoid Arthritis patients: neoplastic diseases / Group 4: Systemic Lupus erythematodes patients: neoplastic diseases / Group 5: Systemic sclerosis patients: neoplastic diseases / Group 6: Cancer patients: ongoing chemotherapy; ongoing immunotherapy; ongoing therapy with biologicals; existence of an auto-immune disease; manifest type 2 diabetes mellitus disease / Group 7: Kidney transplant recipients: patients receiving a second, third or fourth kidney transplant; glucocorticoid or immunosuppressive therapy within the lat 3 months, AB0-incompative kidney transplantation

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in the expression of activation markers of T and B cell subtypes involved in immune regulation. Differences in the expression of activation markers on T and B cell subtypes involved in pro-inflammatory processes. The cellular expression of molecular biomarkers for immune-regulation or inflammatin in the context of autoimmunity, cancer and transplant rejection will be quantified by FACS technology (Flow Cytometry). Whole blood will be used for the isolation of Peripheral Blood monoclonal antibodies for the quantification of distinct biomarkers. Monoclonal antibodies will be used for the staining of surface and intracellular markers (BD Biosciences, USA).

Secondary Outcome Measures

Name	Time	Method
not applicable