Actively Recruiting

Age: 18Years - 80Years
All Genders
ID07226115

Splicing-Based Predictive Learning for Individual Chemotherapy Evaluation in Colorectal Cancer (SPLICE)

Led by City of Hope Medical Center · Updated on 2025-11-10

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Colorectal cancer (CRC) is a major cause of cancer-related death worldwide, and responses to adjuvant chemotherapy after surgery vary greatly among patients. This research aims to develop a machine learning model that predicts how individuals will respond to chemotherapy by analyzing tumor-specific alternative splicing patterns, which may better indicate treatment outcomes than traditional gene expression methods. The study seeks to identify molecular markers that can guide personalized treatment and assess recurrence risk after surgery. The study involves analyzing RNA sequencing data from tumor tissue samples to detect alternative splicing features linked to chemotherapy response. Researchers will develop an assay called SPLICE, based on reverse transcription-quantitative polymerase chain reaction (RT-qPCR), and use machine learning to create a predictive model. This model will be validated independently in separate patient groups, tracking disease-free survival up to five years after treatment. Participants will provide tumor tissue samples and clinical data for analysis. The study will evaluate outcomes such as recurrence-free survival and overall survival for up to 60 months following treatment. By combining molecular data with clinical outcomes, researchers aim to produce a tool that helps predict chemotherapy effectiveness and supports personalized care decisions for colorectal cancer patients.

CONDITIONS

Brief Title

Splicing-based Predictive Learning for Individual Chemotherapy Evaluation in Colorectal Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed stage II-III colorectal cancer (TNM classification, 8th edition)
  • Received standard adjuvant chemotherapy after curative resection
  • Availability of tumor tissue (FFPE or frozen) before chemotherapy
  • Sufficient clinical data for outcome analysis (recurrence, survival)
  • Age 18-80 years
Not Eligible

You will not qualify if you...

  • Inflammatory bowel disease
  • Inadequate RNA quality or lack of consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 60 months from primary tumor treatment

Participants provide tumor tissue samples for RNA splicing isoform testing using the SPLICE assay.

Initial tissue sample collection visit

Long-term Monitoring

Duration - Up to 60 months

Participants are followed for disease recurrence and survival outcomes after chemotherapy treatment.

Follow-up visits as per routine clinical care

Trial Site Locations

Total: 1 location

1

City of Hope Medical Center

Duarte, California, United States, 91010

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Research Team

A

Ajay Goel, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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