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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 : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Zeiser, University of Freiburg

Tracking Information
First Submitted Date July 28, 2019
First Posted Date July 31, 2019
Last Update Posted Date August 20, 2020
Actual Study Start Date July 2016
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 28, 2019)
  • Severity of immune-related adverse events (irAEs) [ Time Frame: 2 years ]
    according to CTCAE
  • Progression-free survival (PFS) [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Role of SNP rs2910164 in Patients Treated With Immune Checkpoint Inhibitors
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
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The rs2910164 genotype will be assessed using DNA isolated from peripheral blood samples and Taqman realtime PCR assays.
Sampling Method Probability Sample
Study Population Adult patients with cancer undergoing immune checkpoint inhibitor therapy
Condition Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 18, 2020)
179
Original Estimated Enrollment
 (submitted: July 28, 2019)
250
Actual Study Completion Date February 2020
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04038996
Other Study ID Numbers SNP_irAE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Robert Zeiser, University of Freiburg
Study Sponsor University of Freiburg
Collaborators Not Provided
Investigators
Principal Investigator: Robert Zeiser, MD University of Freiburg
PRS Account University of Freiburg
Verification Date August 2020