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CMS Oncology Clinical Data Requirements for Genomic Tests

An extensive array of clinical properties can be submitted to the GDC. Properties are considered to be optional, required, or preferred. The requirements for CMS are listed below. General GDC requirements and more details for each property can be found in the GDC Data Dictionary Viewer and in any of the supplied links below.

CMS Clinical Data Table

Term Category Required / Preferred / Optional
Age at diagnosis Diagnosis Required
Sex at birth Demographic Required
Primary diagnosis Diagnosis Required
Site of resection or biopsy Diagnosis Required
Tissue or organ of origin Diagnosis Required
Tumor histologic grade Diagnosis Required
Tumor stage Diagnosis Required
Biopsy class (initial diagnostic biopsy of cancer vs. relapse/refractory) Sample Required
Date of biopsy relative to date of primary diagnosis of cancer (days) Sample Required
Date of biopsy relative to date of genomic test (days) Sample Required
Treatment (yes/no) Treatment Required
Treatment type (first following genomic test) Treatment Required
Therapeutic agent(s) (first following genomic test) Treatment Required
Therapeutic regimen or line of therapy (first following genomic test) Treatment Required
Date of treatment initiation relative to date of genomic test (days) Treatment Required
Radiation treatment (yes/no) Treatment Required
Date of radiation therapy initiation relative to date of genomic test (days) Treatment Required
Referral to a clinical trial (yes/no) Case Required
Progression or recurrence Follow Up Required
Date of progression relative to date of genomic test (days) Follow Up Required
Date of last follow-up relative to date of genomic test (days) Follow Up Required
Vital status at last follow-up (alive/dead) Demographic Required