CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 400 target
Drug / intervention
Diagnostic Test: EXPOSE assay(Small RNA-seq of exosomal miRNAs) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07255729
NCT07255729N/ARecruitingOn TrackUpdated 6mo ago

Machine Learning-Based Exosomal microRNA Signature for Preoperative Staging and Chemotherapy Eligibility in Colon Cancer

City of Hope Medical Center·observational·Posted Dec 1, 2025·Updated Dec 1, 2025

In Brief

An observational study evaluating Diagnostic Test: EXPOSE assay(Small RNA-seq of exosomal miRNAs) and Diagnostic Test: EXPOSE RT-qPCR panel for Colon Cancer. Currently recruiting, targeting 400 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsColon Cancer
CountriesUnited States
Collaborators--

Timeline

N/ARecruitingOverdue
20252026
First PostedDec 1, 2025
Enrollment StartJan 15, 2025
Primary CompletionJun 18, 2026
TodayJul 1, 2026
Enrollment to primary: 1.4 yearsPosted 7 months ago

Interventions

Diagnostic Test: EXPOSE assay(Small RNA-seq of exosomal miRNAs)other

Candidates identified from small RNA sequencing

Diagnostic Test: EXPOSE RT-qPCR panelother

Quantification of exosomal microRNAs (RT-qPCR)