口腔和口咽癌的生存率较低，且发病率持续增加。 确定可溶性 CD44 和总蛋白 (TP) 是否可用于监测头颈癌复发，无论是用于即时检测 (POC) 测试，还是用于监测头颈癌复发。这项多机构非随机临床试验在加州大学圣地亚哥分校进行，测试了一种新型诊断/筛查方法；约翰·霍普金斯大学；大巴尔的摩医疗中心；纽约大学；和圣地亚哥退伍军人事务医院。纳入新近经活检证实、未经治疗的口腔癌和口咽癌的患者。患者于2017年4月至2019年4月入组，并于2022年12月至2023年6月进行数据分析。POC唾液口腔冲洗液测试。在治疗前基线以及治疗完成后3、6、12和18个月收集口腔冲洗液；然后对参与者进行为期三年的随访以确定疾病状况。通过费舍尔精确检验评估基线特征与阳性测试的关联。在调整后的多变量比例风险模型中评估 CD44 或 TP 测试阳性值与无进展生存期的关联。 在 172 名入组患者中，平均 (SD) 年龄为 62.5 (10.2) 岁，其中 122 名 (70.9%) 患者的平均 (SD) 年龄为 62.5 (10.2) 岁。 ）被认定为男性。此外，92 名患者 (53.3%) 从未吸烟，99 名患者 (57.6%) 以前或目前饮酒，113 名患者 (65.7%) 患有口咽癌，其中 95 名患者 (84.1%) 人乳头瘤病毒呈阳性。肿瘤部位与基线测试结果相关；与口咽癌患者（110 名患者中的 85 名 [77.3%]）相比，口腔癌患者的基线 POC 检测阳性率较高（51 名患者中的 47 名 [92.2%]）。使用以 CD44 或 TP 水平作为时变协变量的 Cox 回归模型，较高的 CD44 水平显示出与较高的复发风险存在统计学显着相关性（风险比，1.06；95% CI，1.00-1.12），尽管 TP 水平没有统计学意义。在多变量调整分析中，较高的 CD44 和 TP 水平与复发风险比增加相关，分别为 1.13 (95% CI, 1.04-1.22) 和 3.51 (95% CI, 1.24-9.98)。一项测定试验，使用基于酶联免疫吸附测定的实验室测试对治疗后升高的唾液 CD44 和 TP 水平进行纵向监测，确定患者未来癌症复发的风险增加。 CD44 和 TP 快速 POC 测试具有一定的前景，但该适应症还需要进一步开发。ClinicalTrials.gov 标识符：NCT03148665。

Oral and oropharyngeal cancer have low survival rates, and incidence continues to increase.To determine whether soluble CD44 and total protein (TP) are useful for monitoring head and neck cancer recurrence, either used in a point-of-care (POC) test or as individual laboratory-based biomarkers.This multi-institutional nonrandomized clinical trial testing a novel diagnostic/screening assay took place across the University of California, San Diego; Johns Hopkins University; the Greater Baltimore Medical Center; New York University; and the San Diego Veterans Affairs Hospital. Patients with newly biopsy-proven, untreated oral cavity and oropharyngeal cancer were enrolled. Patients were enrolled April 2017 to April 2019, and data were analyzed December 2022 to June 2023.POC salivary oral rinse test.Oral rinses were collected at pretreatment baseline and 3, 6, 12, and 18 months after completion of therapy; participants were then followed up for 3 years to define disease status. Associations of baseline characteristics with a positive test were evaluated by Fisher exact test. The association of a positive value on the CD44 or TP test with progression-free survival was evaluated in an adjusted multivariable proportional hazards model.Of 172 patients enrolled, the mean (SD) age was 62.5 (10.2) years, and 122 (70.9%) identified as male. Additionally, 92 patients (53.3%) had never smoked, 99 (57.6%) formerly or currently drank alcohol, and 113 (65.7%) presented with oropharyngeal cancers, which were positive for human papillomavirus in 95 (84.1%). Tumor site was associated with test results at baseline; patients with oral cavity cancer had a higher baseline positive POC test rate (47 of 51 [92.2%]) compared to patients with oropharyngeal cancer (85 of 110 [77.3%]). Using Cox regression models with CD44 or TP level as a time-varying covariate, a higher CD44 level showed a statistically significant association with a higher hazard of recurrence (hazard ratio, 1.06; 95% CI, 1.00-1.12), though the TP level was not statistically significant. In multivariate adjusted analysis, higher CD44 and TP levels were associated with increased hazard ratios of recurrence of 1.13 (95% CI, 1.04-1.22) and 3.51 (95% CI, 1.24-9.98), respectively.In this multi-institutional nonrandomized clinical trial of an assay, posttreatment longitudinal monitoring for elevated salivary CD44 and TP levels using an enzyme-linked immunosorbent assay-based laboratory test identified patients at increased risk of future cancer recurrence. The CD44 and TP rapid POC test holds some promise, but further development is needed for this indication.ClinicalTrials.gov Identifier: NCT03148665.