The Role of SNP rs2910164 in Patients Treated With Immune Checkpoint Inhibitors
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
1 other identifier
observational
179
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2016
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedAugust 7, 2023
August 1, 2023
3.6 years
July 28, 2019
August 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Severity of immune-related adverse events (irAEs)
according to CTCAE
2 years
Progression-free survival (PFS)
2 years
Eligibility Criteria
Adult patients with cancer undergoing immune checkpoint inhibitor therapy
You may qualify if:
- 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
You may not qualify if:
- age \< 18 years
- lack of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Jazdzewski K, Murray EL, Franssila K, Jarzab B, Schoenberg DR, de la Chapelle A. Common SNP in pre-miR-146a decreases mature miR expression and predisposes to papillary thyroid carcinoma. Proc Natl Acad Sci U S A. 2008 May 20;105(20):7269-74. doi: 10.1073/pnas.0802682105. Epub 2008 May 12.
PMID: 18474871BACKGROUNDStickel N, Hanke K, Marschner D, Prinz G, Kohler M, Melchinger W, Pfeifer D, Schmitt-Graeff A, Brummer T, Heine A, Brossart P, Wolf D, von Bubnoff N, Finke J, Duyster J, Ferrara J, Salzer U, Zeiser R. MicroRNA-146a reduces MHC-II expression via targeting JAK/STAT signaling in dendritic cells after stem cell transplantation. Leukemia. 2017 Dec;31(12):2732-2741. doi: 10.1038/leu.2017.137. Epub 2017 May 9.
PMID: 28484267BACKGROUNDMarschner D, Falk M, Javorniczky NR, Hanke-Muller K, Rawluk J, Schmitt-Graeff A, Simonetta F, Haring E, Dicks S, Ku M, Duquesne S, Aumann K, Rafei-Shamsabadi D, Meiss F, Marschner P, Boerries M, Negrin RS, Duyster J, Zeiser R, Kohler N. MicroRNA-146a regulates immune-related adverse events caused by immune checkpoint inhibitors. JCI Insight. 2020 Mar 26;5(6):e132334. doi: 10.1172/jci.insight.132334.
PMID: 32125286RESULT
Biospecimen
The rs2910164 genotype will be assessed using DNA isolated from peripheral blood samples and Taqman realtime PCR assays.
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Zeiser, MD
University of Freiburg
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department of Tumorimunnology and Immunoregulation
Study Record Dates
First Submitted
July 28, 2019
First Posted
July 31, 2019
Study Start
July 1, 2016
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
August 7, 2023
Record last verified: 2023-08