Plasma Long Non-Coding RNA RP11-438N5.3 Level for Non-Small Cell Lung Cancer Diagnosis - Letter

Sep 15, 2026

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Letter discussing the diagnostic potential of plasma long non-coding RNA RP11-438N5.3 for non-small cell lung cancer. It summarizes the reported study in which 69 patients and 69 healthy controls underwent plasma RP11-438N5.3 quantification by qRT-PCR and ROC-based evaluation. The letter highlights that the diagnostic accuracy may be affected by limitations in cohort inclusion design, relying on irrelevant healthy controls without appropriate benign or risk-stratified comparators. It recommends a one-gate, pre-specified inclusion/exclusion design and further rigorous validation.

LanguageEnglish

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Dear editor

Summary of the original diagnostic findings

Methodological limitations and control selection

Recommended study design and future evaluation

Cancer Management and Research Dovepress open access to scientiﬁc and medical research Open Access Full Text Article LE TT ER Plasma Long Non-Coding RNA RP11-438N5.3 Level for Non-Small Cell Lung Cancer Diagnosis [Letter] This article was published in the following Dove Press journal: Cancer Management and Research Chun-Qiu Yang 1 Guo-Ming Zhang 2 1 Department of Laboratory Medicine, Taihe County People’s Hospital, Fuyang 236600, People’s Republic of China; 2Department of Laboratory Medicine, Shuyang People’s Hospital, Shuyang Hospital Afﬁliated to Xuzhou Medical University, Shuyang 223600, People’s Republic of China Correspondence: Guo-Ming Zhang Department of Laboratory Medicine, Shuyang People’s Hospital, The Afﬁliated Shuyang Hospital of Xuzhou Medical University, Shuyang 223600, People’s Republic of China [Email gm@xzhmu.edu.cn](Email gm@xzhmu.edu.cn) Dear editor Chen et al 1 published an article entitled “Plasma Long Non-Coding RNA RP11- 438N5.3 as a Novel Biomarker for Non-Small Cell Lung Cancer” in the Cancer Management and Research journal. To evaluate the diagnostic efﬁciency of Plasma level of RP11-438N5.3 for non-small-cell lung cancer (NCLC), the investigators enrolled 69 NCLC patients and 69 healthy controls in this study. Plasma level of RP11-438N5.3 was determined using quantitative reverse transcription PCR (qRTPCR), and receiver operating characteristic (ROC) curve analysis was assessed to determine the diagnostic performance of Plasma level of RP11-438N5.3 level in NCLC. They found that Plasma level of RP11-438N5.3 level was signiﬁcantly lower in NCLC patients than healthy controls and the area under ROC curve (AUC) is 0.814 . Therefore, they concluded that the Plasma level of RP11-438N5.3 was a novel diagnostic biomarker for NCLC. The work performed by Chen et al is novel and interesting for ﬁnding a novel diagnostic non-invasive biomarker for NCLC. However, we would like to point out some limitations of this study. This study was neither pre-designed inclusion nor exclusion criteria for enrolling study cohort consecutively, and controls ofthe study were 69 healthy controls without NCLC. The design of diagnostic tests in this study is not a “one-gate” design study (The NCLC patients and controls are from two completely Irrelevant populations. The number of NCLC patients is crucial, if the proportion of NCLC patients is too high, there will be overestimated sensitivity. Whereas the proportion of controls is high, there will be an inﬂated estimate of sensitivity.2) in this study. Therefore, the diagnostic capability of the design of this study is deeply affected by the Irrelevant healthy controls.3,4 It seems that the appropriate controls (Including benign bowel disease and healthy controls) are crucial for evaluating the diagnostic accuracy. There are any signs, symptoms and risk factors related to NCLC for healthy controls, and there is not necessary to test Plasma level of RP11-438N5.3 to distinguish between healthy controls and NCLC patients. This study should be using “one-gate design” (The NCLC patients and healthy controls are from the relevant population. The proportion of NCLC patients and controls is ﬁxed and constant. Therefore, the sensitivity and speciﬁcity of the diagnostic tests will be constant, as long as the NCLC patients and controls come from the one population.2) for better to using both pre-speciﬁed inclusion and [submit your manuscript](submit your manuscript | www.dovepress.com)[ | www.dovepress.com](submit your manuscript | www.dovepress.com)[ ](submit your manuscript | www.dovepress.com)DovePress [http:](http://doi.org/10.2147/CMAR.S255036)[//doi.org/10.2147/CMAR.S255036](http://doi.org/10.2147/CMAR.S255036) Cancer Management and Research 2020:12 2663–2664 2663 © 2020 Yang and Zhang. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at [https://www.dovepress.com/](https://www.dovepress.

FAQs

What diagnostic biomarker is discussed in this letter?

The letter focuses on plasma long non-coding RNA RP11-438N5.3 as a proposed diagnostic biomarker for non-small cell lung cancer.

How was RP11-438N5.3 measured and evaluated in the referenced study?

Plasma RP11-438N5.3 was measured using quantitative reverse transcription PCR (qRT-PCR), and diagnostic performance was assessed with receiver operating characteristic (ROC) curve analysis.

What key design limitation does the letter criticize?

It criticizes the study as not using a one-gate design and notes that the controls come from an irrelevant population, which may distort sensitivity and diagnostic accuracy estimates.

Sep 15, 2026

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