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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038996
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Zeiser, University of Freiburg

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.

Condition or disease
Cancer

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 2016
Actual Primary Completion Date : February 2020
Actual Study Completion Date : February 2020



Primary Outcome Measures :
  1. Severity of immune-related adverse events (irAEs) [ Time Frame: 2 years ]
    according to CTCAE

  2. Progression-free survival (PFS) [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
The rs2910164 genotype will be assessed using DNA isolated from peripheral blood samples and Taqman realtime PCR assays.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with cancer undergoing immune checkpoint inhibitor therapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038996


Sponsors and Collaborators
University of Freiburg
Investigators
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Principal Investigator: Robert Zeiser, MD University of Freiburg
Publications:
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Responsible Party: Robert Zeiser, Head of Department of Tumorimunnology and Immunoregulation, University of Freiburg
ClinicalTrials.gov Identifier: NCT04038996    
Other Study ID Numbers: SNP_irAE
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Zeiser, University of Freiburg:
immune checkpoint inhibitor
single nucleotide polymorphism
microRNA