Cancer
Conditions
Keywords
immune checkpoint inhibitor, single nucleotide polymorphism, microRNA
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.
Interventions
None listed
Sponsors
University of Freiburg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of immune-related adverse events (irAEs) | 2 years | according to CTCAE |
| Progression-free survival (PFS) | 2 years | — |
Outcome results
None listed