An Exosomal microRNA Signature for Preoperative Staging in Colon Cancer (EXPOSE)

November 20, 2025 updated by: City of Hope Medical Center

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Colon cancer remains one of the leading causes of cancer-related mortality worldwide, and despite advances in screening and surgical techniques, a substantial proportion of patients continue to experience disease recurrence after curative resection. For patients with pathological stage IIB or higher disease, adjuvant chemotherapy is routinely recommended due to their elevated recurrence risk. However, accurately identifying these biologically aggressive cases before surgery remains a major clinical challenge, as current imaging-based staging often underestimates tumor burden and fails to capture underlying malignant potential. This diagnostic gap has hindered the optimal implementation of neoadjuvant chemotherapy (NAC) in colon cancer.

To address this issue, the investigators established the EXPOSE study (Exosomal microRNA Signature for Pre-Operative Stage and Eligibility Evaluation), a multicenter translational research initiative aiming to develop and validate a noninvasive, biologically informed diagnostic assay capable of identifying patients with high-risk colon cancer-equivalent to pathological stage IIB or higher-who may benefit from NAC.

The EXPOSE study will proceed through three structured phases.

  1. In the discovery phase, exosomal microRNAs will be profiled using comprehensive small RNA sequencing to identify key biomarkers reflecting tumor aggressiveness.
  2. In the training phase, the investigators will quantify candidate microRNAs using RT-qPCR and integrate their expression patterns via machine-learning algorithms to construct a predictive model for high-risk disease.
  3. Finally, in the validation phase, the model's reproducibility, diagnostic accuracy, and generalizability will be tested in an independent clinical cohort.

The final EXPOSE assay is expected to serve as a liquid biopsy-based tool for preoperative staging, enabling more precise identification of biologically advanced colon cancer cases. Upon completion, this study will deliver a rigorously validated diagnostic model that combines molecular and clinical data to guide neoadjuvant treatment decisions and enhance personalized care in colon cancer management.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ajay Goel, PhD
  • Phone Number: 626-218-3452
  • Email: AJGOEL@COH.ORG

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91016
        • Recruiting
        • City of Hope Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Colon cancer patients (Stage I-IV) from multiple institutions with preoperative serum or plasma samples and complete pathological staging.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No written informed consent
  • Missing preoperative blood samples
  • Missing survival/recurrence data
  • Duplicate cases
  • Non-adenocarcinoma histology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High-risk Colon Cancer (Discovery)
Stage IIB-IV colon cancer; used to identify biomarker candidates
Diagnostic test: Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）
Candidates identified from small RNA sequencing
Low-risk Colon Cancer (Discovery)
Stage I-IIA colon cancer
Diagnostic test: Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）
Candidates identified from small RNA sequencing
High-risk Colon Cancer (Training)
Pathological Stage IIB-IV; used to build model
Diagnostic test: Diagnostic Test: EXPOSE RT-qPCR panel
Quantification of exosomal microRNAs (RT-qPCR)
Low-risk Colon Cancer (Training)
Pathological Stage I-IIA
Diagnostic test: Diagnostic Test: EXPOSE RT-qPCR panel
Quantification of exosomal microRNAs (RT-qPCR)
High-risk Colon Cancer (Validation)
Stage IIB-IV in independent cohort
Diagnostic test: Diagnostic Test: EXPOSE RT-qPCR panel
Quantification of exosomal microRNAs (RT-qPCR)
Low-risk Colon Cancer (Validation)
Stage I-IIA in independent cohort
Diagnostic test: Diagnostic Test: EXPOSE RT-qPCR panel
Quantification of exosomal microRNAs (RT-qPCR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathological Stage IIB or higher patients
Time Frame: At time of pathology (1year after surgery)
At time of pathology (1year after surgery)

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence-Free Survival (RFS)
Time Frame: Up to 120 months
Up to 120 months
Overall survival (OS)
Time Frame: Up to 120 months
Up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Ajay Goel, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

June 18, 2026

Study Completion (Estimated)

June 18, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/EXPOSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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