Evidence map›Paper›PMID 38504268›Full record

Trial reportMolecular cancer2024

Clinical effectiveness of a multitarget urine DNA test for urothelial carcinoma detection: a double-blinded, multicenter, prospective trial.

Junlong Wu, Yuda Lin, Kaiwei Yang, Xiao Liu, Huina Wang, Tingting Yu, Ran Tao, Jing Guo, Libin Chen, Huanqing Cheng and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyLetter
In one paragraph

Trial report in Molecular cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07360834 (Predicting Cancer Onset in Lynch Syndrome by Liquid Biopsies), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
12.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07360834 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Predicting Cancer Onset in Lynch Syndrome by Liquid Biopsies

TypeinterventionalSponsorUNICANCERRan2026 to 2030Enrolled2,000ConditionsLynch SyndromeArmsINVITRO DIAGNOSTIC TESTS AND COLONOSCOPY
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 2 countries.

Junlong Wu *Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, 200032, People's Republic of China.
Yuda Lin *Department of Urology, Tianjin Institute of Urology, The Second Hospital of Tianjin Medical University, 23 Pingjiang Road, Hexi District, Tianjin, 300211, People's Republic of China.
Kaiwei Yang *Department of Urology, Peking University First Hospital, No. 8 Xishiku Dajie, Xicheng District, Beijing, 100034, People's Republic of China.
Xiao LiuAcornmed Biotechnology Co., Ltd, Beijing, 100176, People's Republic of China.
Huina WangAcornmed Biotechnology Co., Ltd, Beijing, 100176, People's Republic of China.
Tingting YuAcornmed Biotechnology Co., Ltd, Beijing, 100176, People's Republic of China.
Ran TaoAcornmed Biotechnology Co., Ltd, Beijing, 100176, People's Republic of China.
Jing GuoAcornmed Biotechnology Co., Ltd, Beijing, 100176, People's Republic of China.
Libin ChenAcornmed Biotechnology Co., Ltd, Beijing, 100176, People's Republic of China.
Huanqing ChengAcornmed Biotechnology Co., Ltd, Beijing, 100176, People's Republic of China.
Feng LouAcornmed Biotechnology Co., Ltd, Beijing, 100176, People's Republic of China. fenglou@acornmed.com.
Shanbo CaoAcornmed Biotechnology Co., Ltd, Beijing, 100176, People's Republic of China. shanbocao@acornmed.com.
Wei YuDepartment of Urology, Peking University First Hospital, No. 8 Xishiku Dajie, Xicheng District, Beijing, 100034, People's Republic of China. yuweif@126.com.
Hailong HuDepartment of Urology, Tianjin Institute of Urology, The Second Hospital of Tianjin Medical University, 23 Pingjiang Road, Hexi District, Tianjin, 300211, People's Republic of China. huhailong@tmu.edu.cn.
Dingwei YeDepartment of Urology, Fudan University Shanghai Cancer Center, Shanghai, 200032, People's Republic of China. dwyeli@163.com.
Tianjin Medical University · CNAcorn · USFudan University Shanghai Cancer Center · CNPeking University · CNPeking University First Hospital · CNShanghai Medical College of Fudan University · CNVector Oncology (United States) · US

Funding

Scientific Research Project of Tianjin Municipal Education Commission 2022ZD069Shanghai Municipal Health Bureau Project 2020CXJQ03Tianjin Institute of Urology Talent Funding Program MYSRC202310Tianjin Key Medical Discipline (Specialty) Construction Project TJYXZDXK-023ATianjin Municipal Health Industry Key Project TJWJ2022XK014Zhaoyang Cancer Research Fund of The Chinese Society of Clinical Oncology Y-Young2023-0087
6 · The paper itself

Abstract

Urine-based testing is promising for noninvasive diagnosis of urothelial carcinoma (UC) but has suboptimal sensitivity for early-stage tumors. Herein, we developed a multitarget urine tumor DNA test, UI-Seek, for UC detection and evaluated its clinical feasibility. The prediction model was developed in a retrospective cohort (n = 382), integrating assays for FGFR3 and TERT mutations and aberrant ONECUT2 and VIM methylation to generate a UC-score. The test performance was validated in a double-blinded, multicenter, prospective trial (n = 947; ChiCTR2300076543) and demonstrated a sensitivity of 91.37% and a specificity of 95.09%. The sensitivity reached 75.81% for low-grade Ta tumors and exceeded 93% in high-grade Ta and higher stages (T1 to T4). Simultaneous identification of both bladder and upper urinary tract tumors was enabled with sensitivities exceeding 90%. No significant confounding effects were observed regarding benign urological diseases or non-UC malignancies. The test showed improved sensitivities over urine cytology, the NMP22 test, and UroVysion FISH alongside comparable specificities. The single-target accuracy was greater than 98% as confirmed by Sanger sequencing. Post-surgery UC-score decreased in 97.7% of subjects. Overall, UI-Seek demonstrated robust performance and considerable potential for the early detection of UC.

Indexed as

Carcinoma, Transitional CellUrinary Bladder NeoplasmsBiomarkers, TumorDNAHomeodomain ProteinsHumansProspective StudiesRetrospective StudiesSensitivity and SpecificityTranscription FactorsTreatment OutcomeBiomarkers, TumorDNAHomeodomain ProteinsONECUT2 protein, humanTranscription FactorsCancer biomarkersEarly detectionLiquid biopsyMolecular diagnosisUrine tumor DNAUrothelial carcinoma

Identifiers

PMID38504268
PMCPMC10949661
OpenAlexW4392960657

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.