Evidence map›Paper›PMID 41776599›Full record

Observational studyMolecular cancer2026

An exosome-based liquid biopsy to predict molecular residual disease for the identification of high-risk patients with stage II-III colorectal cancer: the CLEAR study.

Katsuki Miyazaki, Blanca Montcusí, Yuji Morine, Keisuke Okuno, Marta Pascual, Takuya Tokunaga, Takayuki Noma, Yusuke Kinugasa, Mitsuo Shimada, Guoxiang Cai and 2 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Molecular cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06654622 (An Exosome-Based Liquid Biopsy Assay to Detect Molecular Residual Disease for the Identification of High-Risk Patients With Stage II-III Colorectal Cancer), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT06654622 completednot on this map

An Exosome-Based Liquid Biopsy Assay to Detect Molecular Residual Disease for the Identification of High-Risk Patients With Stage II-III Colorectal Cancer

Typeobservational_patient_registrySponsorCity of Hope Medical CenterRan2023 to 2026Enrolled175ConditionsColo-rectal Cancer, Colorectal Cancer Recurrent
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

12 authors.

Katsuki MiyazakiDepartment of Molecular Diagnostics and Experimental Therapeutics, Beckman Research Institute of City of Hope, Biomedical Research Center, 1218 S. Fifth Avenue, Suite 2226, Monrovia, CA, 91016, USA.ORCID http://orcid.org/0000-0003-0065-5296
Blanca MontcusíSection of Colon and Rectal Surgery, Department of Surgery, Hospital del Mar, Barcelona, Spain.
Yuji MorineDepartment of Surgery, Tokushima University, Tokushima, Japan.
Keisuke OkunoDepartment of Molecular Diagnostics and Experimental Therapeutics, Beckman Research Institute of City of Hope, Biomedical Research Center, 1218 S. Fifth Avenue, Suite 2226, Monrovia, CA, 91016, USA.
Marta PascualSection of Colon and Rectal Surgery, Department of Surgery, Hospital del Mar, Barcelona, Spain.
Takuya TokunagaDepartment of Surgery, Tokushima University, Tokushima, Japan.
Takayuki NomaDepartment of Molecular Diagnostics and Experimental Therapeutics, Beckman Research Institute of City of Hope, Biomedical Research Center, 1218 S. Fifth Avenue, Suite 2226, Monrovia, CA, 91016, USA.
Yusuke KinugasaDepartment of Gastrointestinal Surgery, Institute of Science Tokyo, Tokyo, Japan.
Mitsuo ShimadaDepartment of Surgery, Tokushima University, Tokushima, Japan.
Guoxiang CaiDepartment of Colorectal Surgery, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China. gxcai@fudan.edu.cn.
Miguel PeraColorectal Neoplasms Clinical and Translational Research Group, Hospital del Mar Research Institute (IMIM), Barcelona, Spain. PERA@clinic.cat.
Ajay GoelDepartment of Molecular Diagnostics and Experimental Therapeutics, Beckman Research Institute of City of Hope, Biomedical Research Center, 1218 S. Fifth Avenue, Suite 2226, Monrovia, CA, 91016, USA. ajgoel@coh.org.

Funding

NIH HHS CA72851, CA181572, CA184792, CA202797, CA227602 and CA296639
6 · The paper itself

Abstract

backgroundExosomal miRNAs have drawn increasing attention in the field of liquid biopsy owing to their high degree of cancer specificity and stability. This study aimed to establish an exosome-based liquid biopsy signature to predict molecular residual disease (MRD) in stage II and III colorectal cancer (CRC).

methodsWe analyzed 175 postoperative serum samples from stage II and III CRC patients from 2 independent institutions, performed quantitative reverse-transcription polymerase chain reaction, and developed and validated a risk-stratification model using logistic regression.

resultsWe first evaluated the expression of the 8 miRNAs identified in our previous tissue-based study in exosomes, and found that 5 of 8 were significantly downregulated in the recurrent group. A panel of 5 miRNAs robustly predicted recurrence after surgery in a training cohort (area under the curve [AUC]: 0.83). Subgroup analysis of the adjuvant chemotherapy (ACT) naïve group demonstrated that recurrence rates were 3.1% (1/32) in the low-risk group and 64.7% (11/17) in the high-risk group. We successfully validated the performance of this exosomal miRNA panel in an independent testing cohort (AUC: 0.77). Furthermore, when we developed our risk model, named Clinical Liquid Biopsy via Exosomes for Assessment of Molecular Residual Disease in Colorectal Cancer Score (CLEAR score), by adding tumor factor and stage to the panel, predictive accuracy was dramatically improved (AUC: 0.84).

conclusionsWe have developed an exosome-based liquid biopsy signature that enables robust detection of MRD in patients with stage II-III CRC. These findings could help facilitate more informed clinical decision-making for ACT.

trial registrationNCT06654622.

Indexed as

Biomarkers, TumorColorectal NeoplasmsExosomesNeoplasm, ResidualAgedFemaleGene Expression Regulation, NeoplasticHumansLiquid BiopsyMaleMicroRNAsMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPrognosisROC CurveBiomarkers, TumorMicroRNAsAdjuvant chemotherapyExosomal miRNALiquid biopsyMolecular residual diseaseStage II-III CRC

Identifiers

PMID41776599
PMCPMC13195916

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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.