Illustrates Domains
GF
Illustrates Variables
SPDEVID
GFREFID
GFTSTDTL
GFRESCAT
GFINHERT
GFSYM
GFSYMTYP
GFSPCCND
GFMETHOD
GFASYDTC
Content
This example shows the representation of genetic findings from a multigene panel test in a pancreatic cancer study. The sponsor ran the test on tumor tissue from the primary and secondary tumors, when available. Details on the specimen handling and characteristics are provided in the Biospecimen (BE/BS) domains previously shown. GFREFID is the specimen reference number assigned in the BS/BE domain. The multigene panel test the sponsor used provided a detailed report. In this report, results were classified into categories (e.g., clinically actionable, pathogenic, pharmacogenetic variant, variant of unknown significance). These result classifications were represented using the GFRESCAT variable. This report also included the total number of mutations present in a tumor specimen (tumor mutation burden (TMB) or mutation load).
GFDTC is the date that the specimen was collected. However, as it was of interest to the sponsor, the NSV GFASYDTC was used to represent the date of the actual testing on the sample.