Department of Surgery, Chungnam National University Sejong Hospital, 20, Bodeum 7-ro, Sejong, South Korea.
E&S Healthcare, 11-3, Techno 1-ro, Yuseong-gu, Daejeon, South Korea.
BMC Cancer. 2022 Jan 3;22(1):12. doi: 10.1186/s12885-021-09055-1.
There is a long-time unmet need for a means to detect breast cancer (BC) using blood. Although mammography is accepted as the gold standard for screening, a blood-based diagnostic can complement mammography and assist in the accurate detection of BC in the diagnostic process period of early diagnosis. We have previously reported the possible use of thioredoxin 1 (Trx1) in serum as a novel means to detect BC. In the present study, we validated the clinical utility of Trx1 to identify BC by testing sera from biopsy-confirmed cancer patients and women without cancer.
We have generated monoclonal antibodies against Trx1 and developed an ELISA kit that can quantitate Trx1 in sera. The level of Trx1 was determined in each serum from women without cancer (n = 114), as well as in serum from patients with BC (n = 106) and other types of cancers (n = 74), including cervical, lung, stomach, colorectal, and thyroid cancer. The sera from BC patients were collected and classified by the subjects' age and cancer stage. In addition to the Trx1 levels of BC patients, several pathological and molecular aspects of BC were analyzed. Test results were retrospectively compared to those from mammography. Each test was duplicated, and test results were analyzed by ROC analysis, one-way ANOVA tests, and unpaired t-tests.
The mean level of Trx1 from women without cancer was 5.45 ± 4.16 (±SD) ng/ml, that of the other malignant cancer patient group was 2.70 ± 2.01 ng/ml, and that from the BC group was 21.96 ± 6.79 ng/ml. The difference among these values was large enough to distinguish BC sera from non-BC control sera with a sensitivity of 97.17% and specificity of 94.15% (AUC 0.990, p < 0.0001). Most Trx1 levels from BC patients' sera were higher than the cut-off value of 11.4 ng/ml regardless of age, stage, histological grade, type, and specific receptors' expression profile of BC. The level of Trx1 could rescue women from most cases of misread or incomplete mammography diagnoses.
These results indicated that the blood level of Trx1 could be an effective and accurate means to assist the detection of BC during the early diagnosis period.
人们长期以来一直需要一种通过血液检测乳腺癌（BC）的方法。虽然乳腺 X 线摄影术被认为是筛查的金标准，但基于血液的诊断方法可以与乳腺 X 线摄影术互补，并有助于在早期诊断过程中准确检测 BC。我们之前曾报道过使用硫氧还蛋白 1（Trx1）作为一种新的血清检测 BC 的方法。在本研究中，我们通过检测经活检证实的癌症患者和无癌症女性的血清，验证了 Trx1 用于识别 BC 的临床效用。
我们生成了针对 Trx1 的单克隆抗体，并开发了一种 ELISA 试剂盒，可以定量血清中的 Trx1。从无癌症女性（n=114）的血清中以及从 BC 患者（n=106）和其他类型癌症（包括宫颈癌、肺癌、胃癌、结直肠癌和甲状腺癌）患者的血清中确定了 Trx1 的水平。BC 患者的血清是根据患者的年龄和癌症分期收集和分类的。除了 BC 患者的 Trx1 水平外，还分析了 BC 的几个病理和分子方面。回顾性比较了检测结果与乳腺 X 线摄影术的结果。每个测试都进行了两次重复，并通过 ROC 分析、单因素方差分析和无配对 t 检验对测试结果进行了分析。
无癌症女性的 Trx1 平均水平为 5.45±4.16（±SD）ng/ml，其他恶性癌症患者组为 2.70±2.01ng/ml，BC 组为 21.96±6.79ng/ml。这些值之间的差异足以区分 BC 血清和非 BC 对照血清，具有 97.17%的敏感性和 94.15%的特异性（AUC 0.990，p<0.0001）。无论年龄、分期、组织学分级、BC 类型和特定受体表达谱如何，大多数 BC 患者血清中的 Trx1 水平均高于 11.4ng/ml 的截断值。Trx1 水平可以挽救大多数被误诊或不完全乳腺 X 线摄影术诊断的女性。
这些结果表明，Trx1 的血液水平可能是一种有效且准确的方法，可在早期诊断期间协助检测 BC。
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