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The Outcomes of Surgical and Nonsurgical Treatment in Patients With Spinal Metastases of Lung Cancer: Protocol for a Prospective Cohort Study
BACKGROUND: 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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9926339/ https://www.ncbi.nlm.nih.gov/pubmed/36716088 http://dx.doi.org/10.2196/38273 |
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author | Hu, Panpan Zhai, Shuheng Liu, Xiaoxie Chu, Hongling Wei, Feng |
author_facet | Hu, Panpan Zhai, Shuheng Liu, Xiaoxie Chu, Hongling Wei, Feng |
author_sort | Hu, Panpan |
collection | PubMed |
description | BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2100048151; http://www.chictr.org.cn/showproj.aspx?proj=129450 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38273 |
format | Online Article Text |
id | pubmed-9926339 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-99263392023-02-15 The Outcomes of Surgical and Nonsurgical Treatment in Patients With Spinal Metastases of Lung Cancer: Protocol for a Prospective Cohort Study Hu, Panpan Zhai, Shuheng Liu, Xiaoxie Chu, Hongling Wei, Feng JMIR Res Protoc Protocol BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2100048151; http://www.chictr.org.cn/showproj.aspx?proj=129450 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38273 JMIR Publications 2023-01-30 /pmc/articles/PMC9926339/ /pubmed/36716088 http://dx.doi.org/10.2196/38273 Text en ©Panpan Hu, Shuheng Zhai, Xiaoxie Liu, Hongling Chu, Feng Wei. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.01.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included. |
spellingShingle | Protocol Hu, Panpan Zhai, Shuheng Liu, Xiaoxie Chu, Hongling Wei, Feng The Outcomes of Surgical and Nonsurgical Treatment in Patients With Spinal Metastases of Lung Cancer: Protocol for a Prospective Cohort Study |
title | The Outcomes of Surgical and Nonsurgical Treatment in Patients With Spinal Metastases of Lung Cancer: Protocol for a Prospective Cohort Study |
title_full | The Outcomes of Surgical and Nonsurgical Treatment in Patients With Spinal Metastases of Lung Cancer: Protocol for a Prospective Cohort Study |
title_fullStr | The Outcomes of Surgical and Nonsurgical Treatment in Patients With Spinal Metastases of Lung Cancer: Protocol for a Prospective Cohort Study |
title_full_unstemmed | The Outcomes of Surgical and Nonsurgical Treatment in Patients With Spinal Metastases of Lung Cancer: Protocol for a Prospective Cohort Study |
title_short | The Outcomes of Surgical and Nonsurgical Treatment in Patients With Spinal Metastases of Lung Cancer: Protocol for a Prospective Cohort Study |
title_sort | outcomes of surgical and nonsurgical treatment in patients with spinal metastases of lung cancer: protocol for a prospective cohort study |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9926339/ https://www.ncbi.nlm.nih.gov/pubmed/36716088 http://dx.doi.org/10.2196/38273 |
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