Recruiting

Biomarker Model

Sponsor:

City of Hope Medical Center

Code:

NCT07255729

Conditions

Colon Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Diagnostic Test: EXPOSE RT-qPCR panel

Study Details

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.

Conditions

Colon Cancer

Study ID

NCT07255729

Start date

Jan 15, 2025

Status verified date

Jul, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

Candidates identified from small RNA sequencing

Diagnostic Test: EXPOSE RT-qPCR panel

Quantification of exosomal microRNAs (RT-qPCR)

Primary outcome measure

  • Pathological Stage IIB or higher patients [ Time Frame: At time of pathology (1year after surgery) ]

Central Contacts and Locations

Central contacts

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91016

Contacts

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • CC
  • NAC
  • miRNA
  • Exosomal miRNA
  • Staging
  • liquid biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-07.