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Novel Circulating Tumor Cell Assay for Detection of Colorectal Adenomas and Cancer.
Tsai, Wen-Sy; You, Jeng-Fu; Hung, Hsin-Yuan; Hsieh, Pao-Shiu; Hsieh, Ben; Lenz, Heinz-Josef; Idos, Gregory; Friedland, Shai; Yi-Jiun Pan, Jennifer; Shao, Hung-Jen; Wu, Jen-Chia; Lai, Jr-Ming; Chang, Shih-En; Mei, Rui; Watson, Drew; Javey, Manana; Nimgaonkar, Ashish.
Afiliación
  • Tsai WS; Division of Colon and Rectal Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan.
  • You JF; College of Medicine, Chang Gung University, Taoyuan, Taiwan.
  • Hung HY; Division of Colon and Rectal Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan.
  • Hsieh PS; Division of Colon and Rectal Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan.
  • Hsieh B; Division of Colon and Rectal Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan.
  • Lenz HJ; CellMax Life Inc., Sunnyvale, California, USA.
  • Idos G; Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine University of Southern California, Los Angeles, California, USA.
  • Friedland S; Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine University of Southern California, Los Angeles, California, USA.
  • Yi-Jiun Pan J; Division of Gastroenterology, Department of Medicine, Stanford University, Stanford, California.
  • Shao HJ; Division of Gastroenterology, Department of Medicine, Stanford University, Stanford, California.
  • Wu JC; CellMax Life Inc., Sunnyvale, California, USA.
  • Lai JM; CellMax Life Inc., Sunnyvale, California, USA.
  • Chang SE; CellMax Life Inc., Sunnyvale, California, USA.
  • Mei R; CellMax Life Inc., Sunnyvale, California, USA.
  • Watson D; CellMax Life Inc., Sunnyvale, California, USA.
  • Javey M; Kit Bio Inc., Los Altos, California, USA.
  • Nimgaonkar A; CellMax Life Inc., Sunnyvale, California, USA.
Clin Transl Gastroenterol ; 10(10): e00088, 2019 10.
Article en En | MEDLINE | ID: mdl-31663904
OBJECTIVES: There is a significant unmet need for a blood test with adequate sensitivity to detect colorectal cancer (CRC) and adenomas. We describe a novel circulating tumor cell (CTC) platform to capture colorectal epithelial cells associated with CRC and adenomas. METHODS: Blood was collected from 667 Taiwanese adults from 2012 to 2018 before a colonoscopy. The study population included healthy control subjects, patients with adenomas, and those with stage I-IV CRC. CTCs were isolated from the blood using the CellMax platform. The isolated cells were enumerated, and an algorithm was used to determine the likelihood of detecting adenoma or CRC. Nominal and ordinal logistic regression demonstrated that CTC counts could identify adenomas and CRC, including CRC stage. RESULTS: The CellMax test demonstrated a significant association between CTC counts and worsening disease status (Cuzick's P value < 0.0001) with respect to the adenoma-carcinoma sequence. The test showed high specificity (86%) and sensitivity across all CRC stages (95%) and adenomatous lesions (79%). The area under the curve was 0.940 and 0.868 for the detection of CRC and adenomas, respectively. DISCUSSION: The blood-based CTC platform demonstrated high sensitivity in detecting adenomas and CRC, as well as reasonable specificity in an enriched symptomatic patient population. TRANSLATIONAL IMPACT: If these results are reproduced in an average risk population, this test has the potential to prevent CRC by improving patient compliance and detecting precancerous adenomas, eventually reducing CRC mortality.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Bioensayo / Neoplasias Colorrectales / Adenoma / Células Neoplásicas Circulantes Tipo de estudio: Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Transl Gastroenterol Año: 2019 Tipo del documento: Article País de afiliación: Taiwán Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Bioensayo / Neoplasias Colorrectales / Adenoma / Células Neoplásicas Circulantes Tipo de estudio: Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Transl Gastroenterol Año: 2019 Tipo del documento: Article País de afiliación: Taiwán Pais de publicación: Estados Unidos