The TR(ACE) Assay is a quantitative in vitro diagnostic test run on the TR(ACE) Instrument intended for the measurement of high molecular weight human DNA from plasma as an aid to monitoring disease progression or response to therapy or recurrent or residual disease.
This study is to establish the clinical performance of the TR(ACE) Assay. Deltas of serial TR(ACE) Assay measurements will be compared to the standard of care physician clinical assessment and RECIST 1.1 criteria evaluation relative to the previous visit. Significant changes in serial TR(ACE) Assay measurements are hypothesized to correlate with disease progression or response.
Study Type
OBSERVATIONAL
Enrollment
450
Serial plasma testing with TR(ACE) Assay
California Cancer Associates for Reseach and Excellence, Inc. (cCare)
Encinitas, California, United States
RECRUITINGClinical Assessment change
Standard of care physician's clinical assessment of disease progression or response compared to previous visit
Time frame: Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months
RECIST 1.1 criteria
RECIST 1.1 criteria of subjects from current to previous visit
Time frame: Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months
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