NCT07255729|Recruiting
An Exosomal microRNA Signature for Preoperative Staging in Colon Cancer
EXPOSE
Machine Learning-Based Exosomal microRNA Signature for Preoperative Staging and Chemotherapy Eligibility in Colon Cancer
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EXPOSE
Machine Learning-Based Exosomal microRNA Signature for Preoperative Staging and Chemotherapy Eligibility in Colon Cancer
Sponsor study identifier
observational
400
1 country
1
Study Start
January 15, 2025
Actual (reported)Primary Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Recent studies have highlighted the potential benefits of neoadjuvant chemotherapy (NAC) in colon cancer; however, its indication is generally limited to cases corresponding to pathological stage IIB or higher. Accurately identifying such high-risk cases before surgery remains challenging using conventional clinical diagnostics alone. Therefore, we hypothesized that integrating molecular biomarkers with preoperative clinical assessment could provide a more precise and sensitive evaluation of tumor aggressiveness. In this context, we focused on exosomal microRNAs, which are actively secreted from tumor cells and remain stable in circulation, and aimed to develop a machine learning-based biomarker panel. To achieve this, we initiated a multicenter study utilizing preoperative plasma samples to establish a reliable biomarker model for risk stratification and treatment decision-making in colon cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 15, 2025
Actual (reported)November 17, 2025
Actual (reported)December 1, 2025
Actual (reported)June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Pathological Stage IIB or higher patients
At time of pathology (1year after surgery)
Recurrence-Free Survival (RFS)
Up to 120 months
Overall survival (OS)
Up to 120 months
Stage IIB-IV colon cancer; used to identify biomarker candidates
Stage I-IIA colon cancer
Pathological Stage IIB-IV; used to build model
Pathological Stage I-IIA
Stage IIB-IV in independent cohort
Candidates identified from small RNA sequencing
Quantification of exosomal microRNAs (RT-qPCR)
Colon cancer patients (Stage I-IV) from multiple institutions with preoperative serum or plasma samples and complete pathological staging.
City of Hope Medical Center
Duarte, California, 91016, United States
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Plasma or serum
Ajay Goel, PhD
City of Hope Medical Center
First Submitted
November 17, 2025
First Posted
December 1, 2025
Study Start
January 15, 2025
Actual (reported)Primary Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A Single Arm Phase II Study to Evaluate Treatment With Gevokizumab in Patients With Stage II/III Colon Cancer Who Are ctDNA-positive After Curative Surgery and Adjuvant Chemotherapy
Stage I-IIA in independent cohort
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Taieb J, Svrcek M, Cohen R, Basile D, Tougeron D, Phelip JM. Deficient mismatch repair/microsatellite unstable colorectal cancer: Diagnosis, prognosis and treatment. Eur J Cancer. 2022 Nov;175:136-157. doi: 10.1016/j.ejca.2022.07.020. Epub 2022 Sep 14.
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Tan PB, Verschoor YL, van den Berg JG, Balduzzi S, Kok NFM, Ijsselsteijn ME, Moore K, Jurdi A, Tin A, Kaptein P, van Leerdam ME, Haanen JBAG, Voest EE, de Miranda NFCC, Schumacher TN, Wessels LFA, Chalabi M. Neoadjuvant immunotherapy in mismatch-repair-proficient colon cancers. Nature. 2025 Dec;648(8094):726-735. doi: 10.1038/s41586-025-09679-4. Epub 2025 Oct 20.
Krsul D, Prenc E, Pozgaj L, Stefok D, Pongrac P, Podolski M, Radicevic AP, Karlovic D, Jerkovic A, Golcic M, Drazic I, Glavas Krsul S, Fuckar Cupic D, Erakovic Haber V, Zelic M. Diagnostic Relevance of miR-185, miR-141, and miR-21 in Colon Carcinoma: Insights into Tumor Sidedness and Reference Gene Selection. Biomedicines. 2025 Oct 10;13(10):2460. doi: 10.3390/biomedicines13102460.
Serafin M, Maka M, Szostek J, Kania I, Jablonska B, Mrowiec S. Side-Specific Prognostic Factors in Colon Cancer: A Retrospective Analysis of Right- and Left-Sided Tumors. Cancers (Basel). 2025 Oct 14;17(20):3315. doi: 10.3390/cancers17203315.
Miranda J, Torri GB, Andreia Maria da Silva M, Monjardim G, Mariussi M, Schmitt LG, Wiethan CP, Ghezzi TL, Ghezzi CLA, Altmayer S, Dias AB, Horvat N. CT diagnostic performance for preoperative staging of colon cancer: a systematic review and meta-analysis. Eur Radiol. 2026 Feb;36(2):1506-1516. doi: 10.1007/s00330-025-11850-4. Epub 2025 Aug 6.
Platt JR, Elliott F, Handley K, Magill L, Quirke P, Seymour MT, West NP, Morton D, Seligmann J, Tolan DJM. CT staging performance in an international trial of neoadjuvant chemotherapy for locally advanced colon cancer. Br J Radiol. 2025 Dec 1;98(1176):2175-2183. doi: 10.1093/bjr/tqaf217.
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Morton D, Seymour M, Magill L, Handley K, Glasbey J, Glimelius B, Palmer A, Seligmann J, Laurberg S, Murakami K, West N, Quirke P, Gray R; FOxTROT Collaborative Group. Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial. J Clin Oncol. 2023 Mar 10;41(8):1541-1552. doi: 10.1200/JCO.22.00046. Epub 2023 Jan 19.
Patel RD, Patel B, Crnogorac-Jurcevic T. Extracellular Vesicle-Derived miRNAs as Diagnostic Biomarkers for Pancreatic Ductal Adenocarcinoma: A Systematic Review of Methodological Rigour and Clinical Applicability. Biomark Insights. 2025 Oct 25;20:11772719251381960. doi: 10.1177/11772719251381960. eCollection 2025.
Xia Y, Li B, Huang Z, Li X, Liu X, Zeng S, Fan Y, Yin J. Entropy-Driven Nucleic Acid Amplifier Based on Spatial Confinement as a "Booster" for Detection of Extracellular Vesicle MicroRNAs to Diagnose Gastric Cancer and Monitor Therapeutic Response. Anal Chem. 2025 Nov 25;97(46):25782-25796. doi: 10.1021/acs.analchem.5c05375. Epub 2025 Nov 3.
Yaghobinejad M, Naji M, Alizadeh AM, Aryanezhad S, Khalighfard S, Asadollahi P, Takzare N, Rastegar T. Identification and validation of stage-specific microRNAs and target genes for prostate cancer: Utilizing bioinformatics tools for diagnostic marker discovery. PLoS One. 2025 Nov 4;20(11):e0315366. doi: 10.1371/journal.pone.0315366. eCollection 2025.
Study Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 7, 2026
Record last verified: 2026-07
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