Specimen Provenance Testing Identifies Contamination That Affects Molecular Prognostic Assay Results in Prostate...

To determine if tissue contamination in histologic specimens can significantly affect the results of prognostic molecular markers that are routinely used as confirmatory tests to safely assign appropriate candidates to prostate cancer active surveillance protocols.

This study evaluates 2134 cases from a single, large urology practice that were successfully tested for DNA specimen provenance verification using short tandem repeat analysis for the presence of a significant level of contaminating DNA. After removal of the contamination, 5 of the samples were retested, and the results of the molecular diagnostic test were compared.

Forty-nine of the 2134 cases (2.3%) sent for DNA provenance analysis were found to possess significant levels of contamination. Of these 49 cases, 7 were resent for a repeat molecular diagnostic test after being decontaminated. Five of these prostate cancer specimens had sufficient tissue and RNA to give a more accurate cell cycle progression (CCP) score. The average absolute change in these patients' CCP scores was 0.48, with a minimum of 0.1-unit and a maximum of 1.0-unit difference. These changes in CCP scores are significant enough to cause meaningful alterations in a patient's calculated 10-year mortality rate, as defined by their combined risk score.

DNA contamination in unstained tissue sections sent for prognostic prostate cancer molecular diagnostic testing occurs in 2.3% of the cases, and can be of a magnitude that affects the results and subsequent clinical decision of appropriateness for active surveillance.