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NCT07255729Recruiting

An Exosomal microRNA Signature for Preoperative Staging in Colon Cancer

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

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
17 Nov 2025
Start date
15 Jan 2025
Primary completion date
18 Jun 2028
Lead sponsor
City of Hope Medical Center
NCT number
NCT07255729

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 15 Jan 2025 to the primary completion date, 18 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
City of Hope Medical Center
Coordinator of this site? Confirm its status
DuarteUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.