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

Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04038996
• Other study ID #: SNP_irAE
• Status: Completed
• Start date: July 2016
• Est. completion date: February 2020

Study information

• Verified date: August 2023
• Source: University of Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Freiburg

References & 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. — View Citation

Marschner 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 regu — View Citation

Stickel 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of immune-related adverse events (irAEs)	according to CTCAE	2 years
Primary	Progression-free survival (PFS)		2 years