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
1 other identifier
observational
400
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2025
CompletedFirst Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 18, 2026
December 1, 2025
November 1, 2025
1.4 years
November 17, 2025
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathological Stage IIB or higher patients
At time of pathology (1year after surgery)
Secondary Outcomes (2)
Recurrence-Free Survival (RFS)
Up to 120 months
Overall survival (OS)
Up to 120 months
Study Arms (6)
High-risk Colon Cancer (Discovery)
Stage IIB-IV colon cancer; used to identify biomarker candidates
Low-risk Colon Cancer (Discovery)
Stage I-IIA colon cancer
High-risk Colon Cancer (Training)
Pathological Stage IIB-IV; used to build model
Low-risk Colon Cancer (Training)
Pathological Stage I-IIA
High-risk Colon Cancer (Validation)
Stage IIB-IV in independent cohort
Low-risk Colon Cancer (Validation)
Stage I-IIA in independent cohort
Interventions
Candidates identified from small RNA sequencing
Quantification of exosomal microRNAs (RT-qPCR)
Eligibility Criteria
Colon cancer patients (Stage I-IV) from multiple institutions with preoperative serum or plasma samples and complete pathological staging.
You may qualify if:
- Pathologically confirmed colon cancer (Stage I-IV, UICC TNM 8th edition)
- Underwent curative-intent resection (with or without perioperative therapy)
- Preoperative plasma (or serum) samples available
- Clinical and prognostic data available
You may not qualify if:
- No written informed consent
- Missing preoperative blood samples
- Missing survival/recurrence data
- Duplicate cases
- Non-adenocarcinoma histology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91016, United States
Related Publications (15)
Morgan E, Arnold M, Gini A, Lorenzoni V, Cabasag CJ, Laversanne M, Vignat J, Ferlay J, Murphy N, Bray F. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN. Gut. 2023 Feb;72(2):338-344. doi: 10.1136/gutjnl-2022-327736. Epub 2022 Sep 8.
PMID: 36604116BACKGROUNDCardoso R, Guo F, Heisser T, Hackl M, Ihle P, De Schutter H, Van Damme N, Valerianova Z, Atanasov T, Majek O, Muzik J, Nilbert MC, Tybjerg AJ, Innos K, Magi M, Malila N, Bouvier AM, Bouvier V, Launoy G, Woronoff AS, Cariou M, Robaszkiewicz M, Delafosse P, Poncet F, Katalinic A, Walsh PM, Senore C, Rosso S, Vincerzevskiene I, Lemmens VEPP, Elferink MAG, Johannesen TB, Korner H, Pfeffer F, Bento MJ, Rodrigues J, Alves da Costa F, Miranda A, Zadnik V, Zagar T, Lopez de Munain Marques A, Marcos-Gragera R, Puigdemont M, Galceran J, Carulla M, Chirlaque MD, Ballesta M, Sundquist K, Sundquist J, Weber M, Jordan A, Herrmann C, Mousavi M, Ryzhov A, Hoffmeister M, Brenner H. Colorectal cancer incidence, mortality, and stage distribution in European countries in the colorectal cancer screening era: an international population-based study. Lancet Oncol. 2021 Jul;22(7):1002-1013. doi: 10.1016/S1470-2045(21)00199-6. Epub 2021 May 25.
PMID: 34048685BACKGROUNDTaieb 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.
PMID: 36115290BACKGROUNDSiegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.
PMID: 38230766BACKGROUNDBurley N, Lee Y, Liu L, Gangi A, Nasseri Y, Atkins K, Zaghiyan K, Murrell Z, Osipov A, Hendifar A, Hitchins M, Gong J. ctDNA-guided adjuvant immunotherapy in colorectal cancer. Immunotherapy. 2024;16(20-22):1197-1202. doi: 10.1080/1750743X.2024.2430941. Epub 2024 Nov 17.
PMID: 39552190BACKGROUNDTan 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.
PMID: 41115454BACKGROUNDKrsul 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.
PMID: 41153743BACKGROUNDSerafin 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.
PMID: 41154372BACKGROUNDMiranda 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. 2025 Aug 6. doi: 10.1007/s00330-025-11850-4. Online ahead of print.
PMID: 40767870BACKGROUNDPlatt 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.
PMID: 40848246BACKGROUNDGosavi R, Heriot A, Narasimhan V, Warrier SK. Perspectives of the Use of Neoadjuvant Therapy in the Management of Locally Advanced and Locally Recurrent Colon Cancer: A Bi-National Survey of Colorectal Surgeons. Asia Pac J Clin Oncol. 2025 Oct 13. doi: 10.1111/ajco.70035. Online ahead of print.
PMID: 41084117BACKGROUNDMorton 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.
PMID: 36657089BACKGROUNDPatel 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.
PMID: 41180592BACKGROUNDXia 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.
PMID: 41182092BACKGROUNDYaghobinejad 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.
PMID: 41187218BACKGROUND
Biospecimen
Plasma or serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ajay Goel, PhD
City of Hope Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2025
First Posted
December 1, 2025
Study Start
January 15, 2025
Primary Completion (Estimated)
June 18, 2026
Study Completion (Estimated)
June 18, 2026
Last Updated
December 1, 2025
Record last verified: 2025-11