The Role of SNP rs2910164 in Patients Treated With Immune Checkpoint Inhibitors

Completed

• Conditions: Cancer

• Registration Number: NCT04038996
• Lead Sponsor: University of Freiburg

Brief Summary

The objective of this study is to investigate whether the SNP rs2910164 in the pre-miR-146a gene is associated with outcome and toxicity of immune checkpoint inhibitor therapy.

Detailed Description

The single nucleotide polymorphism (SNP) rs2910164 within the gene for microRNA-146a (miR-146a) reduces miR-146a expression. Previous studies of the investigators demonstrated that this SNP was associated with increased acute GvHD severity in patients undergoing allogeneic hematopoietic stem cell transplantation. In this prospective, observational study the investigators aim to analyze, whether SNP rs2910164 is associated with severity of immune-related adverse events of immune checkpoint inhibitor therapy. Moreover, association of rs2910164 with outcome parameters will be studied.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2019-07-28
• Study First Submitted QC: 2019-07-28
• Study First Posted: 2019-07-31
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• confirmed diagnosis of cancer
• treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1 or anti-CTLA4)
• age ≥ 18 years
• peripheral blood sample available
• written informed consent
• ability to understand the nature of the study and the study related procedures and to comply with them

Exclusion Criteria

• age < 18 years
• lack of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	2 years
Severity of immune-related adverse events (irAEs)	2 years	according to CTCAE