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Completed

NCT Number: NCT04038996

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Severity of immune-related adverse events (irAEs)

    Time frame: 2 years

    according to CTCAE

  2. Progression-free survival (PFS)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2019
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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