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

University of Freiburg179 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

179

Conditions

Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Severity of immune-related adverse events (irAEs)

according to CTCAE

Time frame: 2 years

Progression-free survival (PFS)

Time frame: 2 years

Data from ClinicalTrials.gov

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