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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Contact Information
Primary
Ajay Goel, PhD
ajgoel@coh.org
626-218-3452
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2026-06-18
Participants
Target number of participants: 400
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center

This content was sourced from clinicaltrials.gov

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