Splicing-based Predictive Learning for Individual Chemotherapy Evaluation in Colorectal Cancer
Part of paid clinical trials in Duarte, California.
- Sponsor
- City of Hope Medical Center
- Study ID
- NCT07226115
- Status
- Recruiting
Conditions
- Colorectal Cancer
- Colorectal Cancer Recurrent
- Colorectal Cancer Stage II
- Colorectal Cancer Stage III
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- SPLICE — OTHERA panel of RNA splicing isoform, whose level is tested in tissue samples derived from the primary tumor.
Study Details
Colorectal cancer (CRC) remains one of the leading causes of cancer-related mortality worldwide. Although adjuvant chemotherapy improves survival after curative resection, its efficacy varies widely among patients. The absence of reliable predictive biomarkers often leads to overtreatment or undertreatment. This study aims to develop a machine learning-based predictive model for adjuvant chemotherapy response using tumor-derived alternative splicing signatures. By integrating RNA-seq data, splicing isoform and clinical outcomes, this study seeks to identify molecular predictors of treatment response and recurrence risk after surgery.
Key Dates
- Start date
- Jun 21, 2024
- Status verified
- Nov 2025
- Primary completion
- Jun 18, 2026
- Completion
- Jun 18, 2026
Study Design
- Enrollment
- 200 participants (estimated)
Arms
- Arm: Non-responders of colorectal cancer (Training Cohort)Non-responders of colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the first cohort
- Arm: Responders of colorectal cancer (Training Cohort)Responders of colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the first cohort
- Arm: Non-responders of colorectal cancer, with recurrent disease (Validation Cohort)Non-responders of colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the second, independent, validation cohort
- Arm: Responders of colorectal cancer (Validation Cohort)Responders of colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the second, independent, validation cohort
Primary Outcome Measure
Recurrence Free Survival [ Time Frame: from date of disease treatment to date of death or up to 60 months ]
Central Contacts
- Ajay Goel, PhD626-218-3452
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 |
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