干预性喉癌试验的试验设计、终点与结果报告：一项基于注册库的分析。
Trial Design, Endpoints and Results Reporting in Interventional Laryngeal Cancer Trials: A Registry-Based Analysis.
文献信息
| PMID | 42813420 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Jin Wang |
| 作者单位 | Medical College of Jinzhou Medical University, Jinzhou, China. |
| 期刊 | Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery |
| SCI 分区 | Q2 |
| IF | 2 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
目的： 描述干预性喉癌研究中的试验设计、终点侧重及公开结果报告情况。
设计： 基于注册库的试验记录描述性研究。
地点： ClinicalTrials.gov；记录检索于2025年7月28日。
参与者： 使用术语“laryngeal cancer”检索到的、且有记录的开始日期在1988年至2025年之间的干预性试验。
主要结局指标： 试验分期、计划入组人数、设计特征、干预策略、注册终点领域、结果发布及终止情况。
结果： 我们识别出404项试验。大多数为早期至中期，入组人数适中，10.6%记录了设盲。总体34.7%记录了随机化，且2009—2025年比1988—2008年更常见。在三个研究时期中，指定生存终点的试验比例从34.2%增至68.4%。生活质量或患者报告终点从11.0%增至36.8%，吞咽终点从6.3%增至17.1%。嗓音终点仍不常见（3.8%—6.6%），21项试验（5.2%）指定了明确的喉保留终点。23.5%的试验发布了结果，16.1%被终止。
结论： 注册信息日益反映生存和以患者为中心的优先事项，尽管明确的喉保留终点和公开张贴的结果仍不常见。未来试验可能受益于喉特异性设计、对喉保留与功能的 consistent 评估及充分随访，以及结果的及时传播。
英文摘要
OBJECTIVES: To characterize trial design, endpoint emphasis and public results reporting in interventional laryngeal cancer studies.
DESIGN: Registry-based descriptive study of trial records.
SETTING: ClinicalTrials.gov; records were retrieved on 28 July 2025.
PARTICIPANTS: Interventional trials retrieved using the term 'laryngeal cancer' and with a documented start date between 1988 and 2025.
MAIN OUTCOME MEASURES: Trial phase, planned enrolment, design features, intervention strategies, registered endpoint domains, results posting and discontinuation.
RESULTS: We identified 404 trials. Most were early-to mid-phase with modest enrolment, and masking was recorded in 10.6%. Randomization was documented in 34.7% overall and was more frequent in 2009-2025 than in 1988-2008. Across three study eras, the proportion of trials specifying survival endpoints increased from 34.2% to 68.4%. Quality-of-life or patient-reported endpoints increased from 11.0% to 36.8%, and swallowing endpoints increased from 6.3% to 17.1%. Voice endpoints remained uncommon (3.8%-6.6%), and 21 trials (5.2%) specified an explicit larynx-preservation endpoint. Results were posted for 23.5% of trials, and 16.1% were discontinued.
CONCLUSIONS: Registrations increasingly reflect survival and patient-centred priorities, although explicit larynx-preservation endpoints and publicly posted results remain uncommon. Future trials may benefit from larynx-specific designs, consistent assessment of larynx preservation and function with adequate follow-up, and timely dissemination of results.