GALEAS™ Bladder膀胱癌基因測試

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什麼是膀胱癌？

膀胱癌是一種常見的癌症，於2022年全球癌症發病率排名中位居第九，而香港每年有超過四百宗新病例1,2。血尿為膀胱癌最常見的徵狀，多於80%的患者會出現此徵狀3。雖然早期膀胱癌的預後情況良好4,5，但膀胱癌的復發機會很高5-7，因此病人在治療後需要接受頻密的覆診檢查以確保沒有復發跡象5。

病徵

由於膀胱腫瘤易碎出血，血尿為膀胱癌最常見的病徵。血尿可分為肉眼可見血尿和顯微鏡下血尿兩種，前者可以直接以肉眼觀察到尿液帶血，後者則只能在顯微鏡下才能觀察到紅血球。然而，除了腫瘤出血外，血尿亦有其他成因，例如尿道感染，良性前列腺增生和月經等8。所以將血尿用作檢測膀胱癌的特異度相對較低8。

檢測方法

以膀胱鏡直接觀察膀胱內部為診斷膀胱癌的黃金標準9。膀胱鏡主要分為可彎性和硬性兩種，當中以可彎性較為常用10。可彎性膀胱鏡為一種直徑約五毫米，長而可彎曲的內窺鏡，經尿道進入膀胱。醫生透過膀胱鏡所拍攝的影像來觀察膀胱內部，亦可以從膀胱壁膜取活組織作其他檢查11,12。然而，膀胱鏡為入侵性檢查，有機會令受檢者受傷流血，尿道感染或膀胱穿孔等13。同時，因血尿接受膀胱鏡檢查而確診膀胱癌的個案不足三成14,15，即是不少患者接受了入侵性、昂貴而又有機會令身體感到不適的檢查。

因此，有需要為血尿患者提供一個價錢相宜、非入侵性和採樣簡單而又能準確地檢測膀胱癌的方法。同時，亦為已接受治療的膀胱癌患者提供一個可靠又方便的跟進檢查手段。

GALEASTM Bladder膀胱癌基因測試介紹

GALEASTM Bladder 由英國生物科技公司 Nonacus Ltd. 夥拍伯明翰大學泌尿科腫瘤研究權威Richard T. Bryan教授及其團隊開發，透過次世代測序（NGS）技術分析尿液中的細胞的基因組，檢測與膀胱癌相關的基因突變，能準確地識別在不同惡性程度和分期中出現的關鍵基因突變。

為什麼選用 GALEASTM Bladder膀胱癌基因測試？

非入侵性

只需使用尿液樣本

減少不必要的入侵性檢查

可以作為膀胱鏡檢查前的分流測試

高靈敏度

利用高靈敏度的 NGS 技術檢測出現於超過 96% 膀胱癌病例的基因突變16，檢測能力媲美膀胱鏡檢查

經臨床研究認證

已於英國三個臨床研究中對710個尿液樣本進行測試16，確保檢測結果準確和可靠

檢測能力

GALEASTM Bladder膀胱癌基因測試於膀胱癌各個分期及等級都有很好的檢測能力：

檢測資料

測試代碼 測試方法 樣本要求 測試所需時間
ONB 次世代測序技術 50ml 尿液（不需要晨早第一次尿液; 室溫保存） 3至4週

參考資料

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  2. 2 “Hong Kong Cancer Registry, Hospital Authority.” Hong Kong Cancer Registry, Hospital Authority, 12 Nov. 2024, www3.ha.org.hk/cancereg/allages.asp.
  3. 3 “Symptoms of Bladder Cancer.” Cancer Research UK, 15 Sept. 2022, www.cancerresearchuk.org/about-cancer/bladder-cancer/symptoms.
  4. 4 “Bladder Cancer Prognosis and Survival Rates.” Cancer.gov, 27 Apr. 2023, www.cancer.gov/types/bladder/survival.
  5. 5 Goodison, Steve, et al. “Bladder Cancer Detection and Monitoring: Assessment of Urine- and Blood-Based Marker Tests.” Molecular Diagnosis & Therapy, vol. 17, no. 2, Mar. 2013, pp. 71–84. https://doi.org/10.1007/s40291-013-0023-x.
  6. 6 Loras, A., et al. “Bladder Cancer Recurrence Surveillance by Urine Metabolomics Analysis.” Scientific Reports, vol. 8, no. 1, June 2018, https://doi.org/10.1038/s41598-018-27538-3.
  7. 7 Chamie, Karim, et al. “Recurrence of High‐risk Bladder Cancer: A Population‐based Analysis.” Cancer, vol. 119, no. 17, June 2013, pp. 3219–27. https://doi.org/10.1002/cncr.28147.
  8. 8 Shirodkar, Samir P., and Vinata B. Lokeshwar. “Bladder Tumor Markers: From Hematuria to Molecular Diagnostics – Where Do We Stand?” Expert Review of Anticancer Therapy, vol. 8, no. 7, June 2008, pp. 1111–23. https://doi.org/10.1586/14737140.8.7.1111.
  9. 9 Ye, Zhangqun, et al. “A Comparison of NBI and WLI Cystoscopy in Detecting Non-muscle-invasive Bladder Cancer: A Prospective, Randomized and Multi-center Study.” Scientific Reports, vol. 5, no. 1, June 2015, https://doi.org/10.1038/srep10905.
  10. 10 SH HO Urology Centre, CUHK. www.surgery.cuhk.edu.hk/shho-urology-centre/health-cystoscopy.asp.
  11. 11 Lenis, Andrew T., et al. “Bladder Cancer.” JAMA, vol. 324, no. 19, Nov. 2020, p. 1980. https://doi.org/10.1001/jama.2020.17598.
  12. 12 “What Is a Cystoscopy.” nhs.uk, 14 Feb. 2024, www.nhs.uk/conditions/cystoscopy/what-is-a-cystoscopy.
  13. 13 Devlies, Wout, et al. “The Diagnostic Accuracy of Cystoscopy for Detecting Bladder Cancer in Adults Presenting With Haematuria: A Systematic Review From the European Association of Urology Guidelines Office.” European Urology Focus, vol. 10, no. 1, Aug. 2023, pp. 115–22. https://doi.org/10.1016/j.euf.2023.08.002.
  14. 14 Buntinx, F., and H. Wauters. “The Diagnostic Value of Macroscopic Haematuria in Diagnosing Urological Cancers: A Meta-analysis.” Family Practice, vol. 14, no. 1, Feb. 1997, pp. 63–68. https://doi.org/10.1093/fampra/14.1.63.
  15. 15 Sutton, James M. “Evaluation of Hematuria in Adults.” JAMA, vol. 263, no. 18, May 1990, p. 2475. https://doi.org/10.1001/jama.1990.03440180081037.
  16. 16 Ward, Douglas G., et al. “Highly Sensitive and Specific Detection of Bladder Cancer via Targeted Ultra-deep Sequencing of Urinary DNA.” European Urology Oncology, vol. 6, no. 1, Apr. 2022, pp. 67–75. https://doi.org/10.1016/j.euo.2022.03.005.
  17. 17 Zhu, Chao-Zhe, et al. “A Review on the Accuracy of Bladder Cancer Detection Methods.” Journal of Cancer, vol. 10, no. 17, Jan. 2019, pp. 4038–44. https://doi.org/10.7150/jca.28989.
  18. 18 Alimi, Quentin, et al. “Reliability of Urinary Cytology and Cystoscopy for the Screening and Diagnosis of Bladder Cancer in Patients With Neurogenic Bladder: A Systematic Review.” Neurourology and Urodynamics, vol. 37, no. 3, Sept. 2017, pp. 916–25. https://doi.org/10.1002/nau.23395.