Recruiting

Predictive Model

Sponsor:

City of Hope Medical Center

Code:

NCT07226115

Conditions

Colorectal Cancer

Colorectal Cancer Recurrent

Colorectal Cancer Stage II

Colorectal Cancer Stage III

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SPLICE

Study Details

Brief summary:

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.

Conditions

Colorectal Cancer

Colorectal Cancer Recurrent

Colorectal Cancer Stage II

Colorectal Cancer Stage III

Study ID

NCT07226115

Start date

Jun 21, 2024

Status verified date

Jul, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Stage

Exclusion Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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

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

Interventions

SPLICE

A panel of RNA splicing isoform, whose level is tested in tissue samples derived from the primary tumor.

Primary outcome measure

  • Recurrence Free Survival [ Time Frame: from date of disease treatment to date of death or up to 60 months ]

Central Contacts and Locations

Central contacts

Ajay Goel, PhD

626-218-3452AJGOEL@COH.ORG

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Ajay Goel, PhD

626-218-3452AJGOEL@COH.ORG

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Chemotherapy
  • Adjuvant
  • Response
  • Splicing
  • Prediction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-07.