Health TrialsbyHealthPanel

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

ConditionsColorectal CancerColorectal Cancer RecurrentColorectal Cancer Stage IIColorectal Cancer Stage III
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Inflammatory bowel disease

Inadequate RNA quality or lack of consent

Trial population

Two independent cohorts of colorectal cancer patients treated with adjuvant chemotherapy after curative-intent surgery.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • SPLICE

    Other intervention

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

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Non-responders of colorectal cancer (Training Cohort)1 intervention
Group B: Responders of colorectal cancer (Training Cohort)1 intervention
Group C: Non-responders of colorectal cancer, with recurrent disease (Validation Cohort)1 intervention
Group D: Responders of colorectal cancer (Validation Cohort)1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

Source ClinicalTrials.gov
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