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Report for Clinical Trial NCT04038996

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Single-Center, Prospective, Observational Trial to Analyze the Relationship Between Single Nucleotide Polymorphism rs2910164 and the Efficacy and Safety of Immune Checkpoint Inhibitor Therapy

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.

NCT04038996 Cancer


Primary Outcomes

Description: according to CTCAE

Measure: Severity of immune-related adverse events (irAEs)

Time: 2 years

Measure: Progression-free survival (PFS)

Time: 2 years

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 rs2910164

A Single-Center, Prospective, Observational Trial to Analyze the Relationship Between Single Nucleotide Polymorphism rs2910164 and the Efficacy and Safety of Immune Checkpoint Inhibitor Therapy.

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

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 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 Cancer The single nucleotide polymorphism (SNP) rs2910164 within the gene for microRNA-146a (miR-146a) reduces miR-146a expression.

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.



HPO Nodes