Liquid Biopsy for Detection of Pancreaticobiliary Cancers by Functional Enrichment and Immunofluorescent Profiling of Circulating Tumor Cells and Their Clusters.

Simple Summary: Cancers of the pancreas, gallbladder and bile duct (pancreaticobiliary tract) are often aggressive with poor survival. However, these cancers are not easily identifiable or detected because of vague (non-specific) symptoms and the absence of accurate blood tests. The diagnosis of these cancers involves imaging or endoscopy followed by sampling (biopsy) of suspected tissue for histopathological examination (HPE). Where the tissue sample is not of acceptable quality or is insufficient, the diagnosis (and treatment) can be hindered or delayed. In this manuscript, we describe a blood test that can detect pancreaticobiliary tract cancers with high accuracy. The test may be able to facilitate timely diagnosis of these cancers in suspected patients, especially where tissue-sampling-based diagnosis has been inconclusive or is not possible. Circulating tumor cells (CTCs) have historically been used for prognostication in oncology. We evaluate the performance of liquid biopsy CTC assay as a diagnostic tool in suspected pancreaticobiliary cancers (PBC). The assay utilizes functional enrichment of CTCs followed by immunofluorescent profiling of organ-specific markers. The performance of the assay was first evaluated in a multicentric case-control study of blood samples from 360 participants, including 188 PBC cases (pre-biopsy samples) and 172 healthy individuals. A subsequent prospective observational study included pre-biopsy blood samples from 88 individuals with suspicion of PBC and no prior diagnosis of cancer. CTCs were harvested using a unique functional enrichment method and used for immunofluorescent profiling for CA19.9, Maspin, EpCAM, CK, and CD45, blinded to the tissue histopathological diagnosis. TruBlood ® malignant or non-malignant predictions were compared with tissue diagnoses to establish sensitivity and specificity. The test had 95.9% overall sensitivity (95% CI: 86.0–99.5%) and 92.3% specificity (95% CI: 79.13% to 98.38%) to differentiate PBC (n = 49) from benign conditions (n = 39). The high accuracy of the CTC-based TruBlood test demonstrates its potential clinical application as a diagnostic tool to assist the effective detection of PBC when tissue sampling is unviable or inconclusive. [ABSTRACT FROM AUTHOR]

Copyright of Cancers is the property of MDPI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)