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

NCT ID: NCT04038996

Last Updated: 2023-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-02-29

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Freiburg

OTHER

Sponsor Role lead

Responsible Party

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Robert Zeiser

Head of Department of Tumorimunnology and Immunoregulation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Zeiser, MD

Role: PRINCIPAL_INVESTIGATOR

University of Freiburg

References

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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.

Reference Type BACKGROUND
PMID: 18474871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28484267 (View on PubMed)

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 regulates immune-related adverse events caused by immune checkpoint inhibitors. JCI Insight. 2020 Mar 26;5(6):e132334. doi: 10.1172/jci.insight.132334.

Reference Type RESULT
PMID: 32125286 (View on PubMed)

Other Identifiers

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SNP_irAE

Identifier Type: -

Identifier Source: org_study_id

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