An observational study in Colorectal Cancer, Colorectal Cancer Recurrent and Colorectal Cancer Stage II, sponsored by City of Hope Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by City of Hope Medical Center · Observational
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.
Colorectal cancer (CRC) remains a major global health burden, with adjuvant chemotherapy representing the standard of care after curative resection. However, patient responses to therapy vary widely, and no validated molecular model currently guides adjuvant treatment selection.
Recent studies suggest that aberrant alternative splicing-rather than gene-level expression alone-plays a crucial role in shaping chemotherapy sensitivity and tumor recurrence. Yet, these complex transcriptomic variations are often missed by standard differential expression analyses.
The ASPAIRE framework (Alternative Splicing and Predictive mAchIne learnIng for Response Evaluation) applies advanced computational modeling to capture multidimensional splicing features from RNA-seq data and transform them into clinically actionable predictions.
In this research effort, the investigators will leverage machine learning to predict adjuvant chemotherapy response for CRC. The research plan will employ three phases:
At the end of this study, this assay will have been developed and validated to help clinical decision-making by predicting both disease free survival.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 200 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Two independent cohorts of colorectal cancer patients treated with adjuvant chemotherapy after curative-intent surgery.
Exclusion Criteria:
Non-responders of colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the first cohort
Other: SPLICE
Responders of colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the first cohort
Other: SPLICE
Non-responders of colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the second, independent, validation cohort
Other: SPLICE
Responders of colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the second, independent, validation cohort
Other: SPLICE
A panel of RNA splicing isoform, whose level is tested in tissue samples derived from the primary tumor.
Recurrence Free Survival
Time from disease treatment to development of recurrent colorectal cancer
Time frame: from date of disease treatment to date of death or up to 60 months
Overall survival
Time from disease treatment to death from any cause
Time frame: from date of disease treatment to date of death or up to 60 months
Plan to share: No — Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data.
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