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Feasibility of Pooled One-Step Nucleic Acid Amplification for Molecular Staging of Pathologically Node-Negative Colon Cancer: A Prospective Multicenter Study

  • Colorectal Cancer
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Although conventional one-step nucleic acid amplification (OSNA) is a useful molecular-staging method, its complexity hinders its use in clinical practice. A pooled approach for OSNA (pOSNA) has been evaluated for its feasibility in pathologically node-negative colon cancer (pNNCC) for molecular staging of lymph node metastasis in clinical practice.

Methods

Subjects were patients diagnosed with clinical stage II–IIIA colon cancer between January 2017 and September 2018. pOSNA involved harvesting pericolic lymph nodes from fresh surgical specimens, cutting them in half, placing 50% of the nodes in a single test tube, and performing the OSNA assay. The remaining halved pericolic, intermediate, and main lymph nodes were submitted for histopathologic examination, with metastasis determined by hematoxylin and eosin staining of a cut surface of each node.

Results

Of the 98 enrolled patients, 92 formed the analysis set. The mean number of harvested lymph nodes per case was 24.3 (range 5–66) and the mean number of lymph nodes used for pOSNA analysis was 6.9 (range 1–35). The concordance rate, sensitivity, and specificity between methods were 89.1%, 84.6% (95% confidence interval [CI] 0.80–0.91), and 90.9% (95% CI 0.88–0.94), respectively. The pOSNA upstaging rate for node-negative patients was 9.1% (6/66), and pOSNA returned false-negative results in 15.4% of node-positive cases (4/26).

Conclusions

pOSNA demonstrated an upstaging rate for pNNCC equivalent to that in previous studies, suggesting its feasibility for molecular staging of pNNCC in clinical practice.

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Acknowledgment

Editorial support based on the authors’ detailed directions in the form of medical writing, assembling tables, creating high-resolution images, collating author comments, copyediting, fact checking, and referencing was provided by Editage (Cactus Communications). Conduct of the research and preparation of the article was funded by Sysmex Corporation.

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Authors and Affiliations

  1. Department of Surgery, Institute of Gastroenterology, Tokyo Women’s Medical University, Shinjuku-ku, Tokyo, Japan

    Kimitaka Tani MD, Michio Itabashi MD, PhD, Shimpei Ogawa MD, PhD & Masakazu Yamamoto MD, PhD

  2. Department of Surgery, Surgical Oncology, and Science, Sapporo Medical University, Sapporo, Hokkaido, Japan

    Koichi Okuya MD, PhD, Kenji Okita MD, PhD & Ichiro Takemasa MD, PhD

  3. Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan

    Naohiro Tomita MD, PhD

  4. Cancer Treatment Center, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan

    Naohiro Tomita MD, PhD

  5. Department of Surgical Pathology, Tokyo Women’s Medical University, Shinjuku-ku, Tokyo, Japan

    Yoji Nagashima MD, PhD

Authors
  1. Kimitaka Tani MD
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  2. Michio Itabashi MD, PhD
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  3. Koichi Okuya MD, PhD
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  4. Kenji Okita MD, PhD
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  5. Ichiro Takemasa MD, PhD
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  6. Naohiro Tomita MD, PhD
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  7. Shimpei Ogawa MD, PhD
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  8. Yoji Nagashima MD, PhD
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  9. Masakazu Yamamoto MD, PhD
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Corresponding author

Correspondence to Michio Itabashi MD, PhD.

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Disclosures

This study was supported by Sysmex Corporation (Kobe, Japan). Naohiro Tomita, Taiho Pharmaceutical Co., Chugai Pharmaceutical Co., Kimitaka Tani, Michio Itabashi, Koichi Okuya, Kenji Okita, Ichiro Takemasa, Naohiro Tomita, Shimpei Ogawa, Yoji Nagashima, and Masakazu Yamamotohave no disclosures to declare.

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Tani, K., Itabashi, M., Okuya, K. et al. Feasibility of Pooled One-Step Nucleic Acid Amplification for Molecular Staging of Pathologically Node-Negative Colon Cancer: A Prospective Multicenter Study. Ann Surg Oncol 28, 8804–8812 (2021). https://doi.org/10.1245/s10434-021-10140-9

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  • DOI: https://doi.org/10.1245/s10434-021-10140-9

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