Clinical Research Center, Hospital Sultanah Bahiyah, Alor Setar, Kedah, Malaysia.
Gastroenterology unit, Medical Department, Hospital Sultanah Bahiyah, Alor Setar, Kedah, Malaysia.
Asian Pac J Cancer Prev. 2023 Sep 1;24(9):3183-3186. doi: 10.31557/APJCP.2023.24.9.3183.
Colorectal neoplasia is a multistep process that can lead to the development of colorectal cancer. Colonoscopy is the gold standard for diagnosis and screening of colorectal cancer, but its uptake is often hindered by unpleasant experiences and logistic obstacles. Therefore, non-invasive biomarker tests such as the M2-pyruvate kinase (M2PK) test have been explored as a potential screening tool.
This study aims to evaluate the efficacy of the M2PK Quick Stool Test (ScheBo®) in detecting colorectal adenoma and adenocarcinoma in high-risk Malaysian populations using colonoscopy as the comparison.
A prospective, cross-sectional, multicenter study was conducted from December 2017 to December 2019 in four hospitals in Malaysia. Participants were eligible if they met any of the following criteria: personal or family history of colorectal polyps or cancer, inherited syndromes, altered bowel habits, rectal bleeding, unintended weight loss, loss of appetite, abdominal pain or cramps, or unexplained iron deficiency, or an Asia-Pacific Colorectal Screening score of 4-7. Participants provided a stool sample that was tested for M2PK using the M2PK Quick Test. Participants then underwent a colonoscopy, and any lesions found were biopsied and sent for histopathological examination.
A total of 562 participants were included in the study, of whom 89 had a positive M2PK test. Presence of adenoma and/or dysplastic lesions were confirmed in 14.4% and adenocarcinoma in 3.0% of the participants. The M2PK Quick Stool Test showed a sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of 58.8%, 85.5%, 11.2% and 98.5%, respectively in detecting colorectal adenocarcinoma. For detection of colorectal adenoma, this test yielded a sensitivity, specificity, PPV and NPV of 27.3%, 86.3%, 27.0% and 86.5%, respectively.
The M2PK Quick Stool Test showed a moderate accuracy in detecting colorectal adenocarcinoma and adenomas in the studied population.
结直肠肿瘤是一个多步骤的过程，可导致结直肠癌的发生。结肠镜检查是结直肠癌诊断和筛查的金标准，但由于其带来的不愉快体验和后勤障碍，其采用率往往受到阻碍。因此，人们探索了 M2-丙酮酸激酶（M2PK）等非侵入性生物标志物检测作为一种潜在的筛查工具。
本研究旨在评估 M2PK 快速粪便检测（ScheBo®）在马来西亚高危人群中检测结直肠腺瘤和腺癌的功效，以结肠镜检查为对照。
一项前瞻性、横断面、多中心研究于 2017 年 12 月至 2019 年 12 月在马来西亚的 4 家医院进行。如果参与者符合以下任何标准，则有资格入组：个人或家族结直肠息肉或癌症史、遗传性综合征、排便习惯改变、直肠出血、非故意体重减轻、食欲不振、腹痛或痉挛、或不明原因的缺铁，或亚太结直肠筛查评分 4-7 分。参与者提供粪便样本，使用 M2PK 快速检测试剂盒检测 M2PK。然后参与者接受结肠镜检查，并对发现的任何病变进行活检，并送组织病理学检查。
共有 562 名参与者入组研究，其中 89 名 M2PK 检测阳性。14.4%的参与者存在腺瘤和/或发育不良病变，3.0%的参与者存在腺癌。M2PK 快速粪便检测在检测结直肠腺癌时的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）分别为 58.8%、85.5%、11.2%和 98.5%。在检测结直肠腺瘤时，该检测的敏感性、特异性、PPV 和 NPV 分别为 27.3%、86.3%、27.0%和 86.5%。
在研究人群中，M2PK 快速粪便检测在检测结直肠腺癌和腺瘤方面具有中等准确性。
