An observational study in Colon Cancer, sponsored by City of Hope Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by City of Hope Medical Center · Observational
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.
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.
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 400 is above the median of 280 across 349 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Colon cancer patients (Stage I-IV) from multiple institutions with preoperative serum or plasma samples and complete pathological staging.
Exclusion Criteria:
Stage IIB-IV colon cancer; used to identify biomarker candidates
Diagnostic Test: Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）
Stage I-IIA colon cancer
Diagnostic Test: Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）
Pathological Stage IIB-IV; used to build model
Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panel
Pathological Stage I-IIA
Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panel
Stage IIB-IV in independent cohort
Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panel
Stage I-IIA in independent cohort
Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panel
Candidates identified from small RNA sequencing
Quantification of exosomal microRNAs (RT-qPCR)
Pathological Stage IIB or higher patients
Time frame: At time of pathology (1year after surgery)
Recurrence-Free Survival (RFS)
Time frame: Up to 120 months
Overall survival (OS)
Time frame: Up to 120 months
Plan to share: Undecided — 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
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