Hu Panpan, Zhai Shuheng, Liu Xiaoxie, Chu Hongling, Wei Feng
Department of Orthopedics, Peking University Third Hospital, Beijing, China.
Engineering Research Center of Bone and Joint Precision Medicine, Peking University Third Hospital, Beijing, China.
JMIR Res Protoc. 2023 Jan 30;12:e38273. doi: 10.2196/38273.
Spinal metastases of lung cancer (SMLC) usually have a high degree of malignancy and require multimodality treatment. Patients with SMLC who experience clinical symptoms (eg, local pain, emerging or potential spinal instability, and progressive neurological dysfunction) require surgical treatment. However, there are discrepancies in the comparison of outcomes between surgical treatment and nonsurgical treatment.
This paper presents the protocol for a study that aims to compare the clinical outcomes of surgical treatment and nonsurgical treatment for SMLC, explore the prognostic factors of SMLC, and establish a survival prediction model based on these prognostic factors.
This is a prospective cohort study, with an anticipated sample size of 240 patients (120 patients in the surgical group and 120 patients in the nonsurgical group). We will collect baseline data, including demographic, clinical, and radiological information, as well as data from patient-reported questionnaires. Patients will be followed up at 3, 6, 12, and 24 months after treatment, and survival status will be assessed every 3 months. The primary outcome is the overall survival period. Prognostic factors associated with overall survival will be analyzed by univariate and multivariate Cox proportional hazards regression. Odds ratios with 95% CIs will be presented. Statistical significance is set at P<.05.
This study has been approved by our institute's Medical Science Research Ethics Committee (IRB00006761-M2021085) after a careful audit of the design and content. Patient enrollment began in June 2022 at our hospital. Data collection is expected to be completed by early 2026, and the study results will be published by mid-2027.
In this study, we propose to set up a prospective cohort of patients with SMLC to investigate the outcomes between surgical treatment and nonsurgical treatment. We will explore the role of surgical treatment in SMLC and provide guidance to peer surgeons.
Chinese Clinical Trial Registry, ChiCTR2100048151; http://www.chictr.org.cn/showproj.aspx?proj=129450.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38273.
肺癌脊柱转移（SMLC）通常具有高度恶性，需要多模式治疗。出现临床症状（如局部疼痛、新发或潜在脊柱不稳定以及进行性神经功能障碍）的SMLC患者需要手术治疗。然而，手术治疗与非手术治疗的疗效比较存在差异。
本文介绍一项研究方案，旨在比较SMLC手术治疗与非手术治疗的临床疗效，探索SMLC的预后因素，并基于这些预后因素建立生存预测模型。
这是一项前瞻性队列研究，预期样本量为240例患者（手术组120例患者，非手术组120例患者）。我们将收集基线数据，包括人口统计学、临床和放射学信息，以及患者报告问卷的数据。患者将在治疗后3、6、12和24个月进行随访，每3个月评估生存状态。主要结局是总生存期。将通过单因素和多因素Cox比例风险回归分析与总生存期相关的预后因素。将呈现具有95%置信区间的比值比。统计学显著性设定为P<0.05。
本研究经我院医学科研伦理委员会（IRB00006761-M2021085）对设计和内容进行仔细审核后批准。患者入组于2022年6月在我院开始。数据收集预计于2026年初完成，研究结果将于2027年年中发表。
在本研究中，我们提议建立一个SMLC患者的前瞻性队列，以研究手术治疗与非手术治疗的疗效。我们将探索手术治疗在SMLC中的作用，并为同行外科医生提供指导。
中国临床试验注册中心，ChiCTR2100048151；http://www.chictr.org.cn/showproj.aspx?proj=129450。
国际注册报告识别码（IRRID）：DERR1-10.2196/38273。
