Clinical trial NCT02609269: Decipher Genomics Resource for Intelligent Discovery
Official title: Prospective Expression Analysis Using The Decipher Genomics Resource for Intelligent Discovery (GRID)® and Data Sharing Program
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Prostate Cancer
Bladder Cancer
Renal Cancer
Keywords: Decipher
Transcriptome
Gene Expression
Lead sponsor: GenomeDx Biosciences Corp
Sponsor class: INDUSTRY
Collaborators: name: Veracyte, Inc.
First posted: 2015-11-20
Enrollment: 1000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Decipher testing in the clinical setting. It is understood that the Decipher test results may be used as a part of normal clinical care. Any patient meeting the following criteria who has been tested with Decipher can participate in the study.

Brief summary: To prospectively evaluate the utility of genomic expression data as a tool to better characterize the tumors of individual patients, and to understand how genomic information from individual patients undergoing routine clinical testing can be used in population-level analysis to improve treatment and outcomes.

Detailed description: Observational study involving the release of tumor genome-wide expression data generated by the Decipher assay which will be linked to clinical treatment and outcome data for patients in whom Decipher clinical testing was performed. The GRID database population will be used to characterize the genomics of cancer and discover or validate gene expression signatures that may be useful for understanding of the biology of the disease and implementing precision medicine approaches for cancer patients.

Eligibility criteria: Inclusion Criteria:

Subjects that have had a Decipher clinical test

Primary outcomes:
measure: Link complete genomic RNA expression array data generated from Decipher testing with clinical data for patients who consent to participate.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Veracyte, Inc.
name: Elai Davicioni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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