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癌症恶病质临床试验概况:1995 - 2024年趋势评估

Landscape of clinical trials in cancer cachexia: assessment of trends from 1995-2024.

作者信息

Cabrera Ana Regina, Parker Kaitlyn, Snoke Deena B, Hammig Bart, Greene Nicholas P

机构信息

Department of Health, Human Performance and Recreation, Exercise Science Research Center, Cachexia Research Laboratory, University of Arkansas, Fayetteville, AR, USA.

Department of Medicine, University of Vermont College of Medicine, Burlington, VT, USA.

出版信息

BMC Cancer. 2025 Aug 4;25(1):1265. doi: 10.1186/s12885-025-14555-5.

Abstract

BACKGROUND

Cancer cachexia, a multifactorial syndrome characterized by unintentional weight loss, is a frequent complication of cancer that impacts patients’ quality of life and survival.

METHODS

In this retrospective review, we evaluated the landscape of clinical trials registered on ClinicalTrials.gov for the consideration of potential factors contributing to biological human heterogeneity in their design and analyses.

RESULTS

Among clinical trials registered from 1995–2024, we observed increased inclusion of female participants, but lack of reporting of sex as a biological variable. The majority (~ 93%) of participants were of Caucasian descent. There was a substantial divergence in the diagnostic criteria and a wide range of tools employed to measure cancer cachexia. Lastly, few studies considered cancer type and stage as clinical variables.

CONCLUSION

Overall, a substantial gap remains in our knowledge of cancer cachexia in non-white individuals and in females. Ultimately, these underreported data across cancer cachexia clinical trials complicate the comparison and interpretation of clinical trials results, both in the broader human population and in specific cancer types. The current evolution of knowledge and new methodologies used for cancer cachexia assessment reinforce the need for a constant revision of the consensus definition and diagnosis criteria to align with current advances in our understanding of human heterogeneity in cancer cachexia.

GRAPHICAL ABSTRACT

[Image: see text]

SUPPLEMENTARY INFORMATION

The online version contains supplementary material available at 10.1186/s12885-025-14555-5.

摘要

背景

癌症恶病质是一种以非自愿体重减轻为特征的多因素综合征,是癌症常见的并发症,会影响患者的生活质量和生存期。

方法

在这项回顾性研究中,我们评估了在ClinicalTrials.gov上注册的临床试验情况,以考虑其设计和分析中导致人类生物学异质性的潜在因素。

结果

在1995年至2024年注册的临床试验中,我们观察到女性参与者的纳入有所增加,但作为生物学变量的性别报告缺失。大多数(约93%)参与者为白种人后裔。癌症恶病质的诊断标准存在很大差异,用于测量癌症恶病质的工具种类繁多。最后,很少有研究将癌症类型和分期视为临床变量。

结论

总体而言,我们对非白人个体和女性癌症恶病质的了解仍存在很大差距。最终,这些癌症恶病质临床试验中报告不足的数据使临床试验结果在更广泛人群和特定癌症类型中的比较和解释变得复杂。目前癌症恶病质评估的知识进展和新方法强化了不断修订共识定义和诊断标准以跟上我们对癌症恶病质中人类异质性理解的当前进展的必要性。

图形摘要

[图片:见正文]

补充信息

在线版本包含可在10.1186/s12885-025-14555-5获取的补充材料。

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