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.
循环肿瘤细胞（CTCs）在肿瘤学中历来被用于预后评估。本研究评估了液体活检CTC检测作为疑似胰胆管癌（PBC）诊断工具的性能。该检测方法采用CTC功能富集技术，随后对器官特异性标志物进行免疫荧光分析。首先通过一项多中心病例对照研究评估了该检测的性能，该研究纳入了360名参与者的血液样本，包括188例PBC患者（活检前样本）和172名健康个体。随后一项前瞻性观察性研究纳入了88例疑似PBC且既往无癌症诊断个体的活检前血液样本。采用独特的功能富集方法分离CTCs，并针对CA19.9、Maspin、EpCAM、CK和CD45进行免疫荧光分析，分析过程对组织病理学诊断结果设盲。将TruBlood®检测的恶性或非恶性预测结果与组织病理诊断进行比对，以确定其敏感性和特异性。该检测在区分PBC（n=49）与良性病变（n=39）时，总体敏感性达95.9%（95% CI：86.0–99.5%），特异性为92.3%（95% CI：79.13%至98.38%）。基于CTC的TruBlood检测所展现的高准确性，证明了其在组织取样不可行或结果不明确时，作为辅助有效检测PBC的诊断工具具有潜在的临床应用价值。
肿瘤(癌症)患者之家