Alternative Splicing Based Prediction of Chemotherapy Response in Gastric Cancer

NCT07587229 | Recruiting

• 1 other identifier: 23228/VERSA
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop a model to predict response to chemotherapy in gastric cancer using RNA splicing information from tumor tissue. By analyzing genetic patterns and applying machine learning, the study seeks to identify patients who are less likely to benefit from treatment, helping guide clinical decision-making.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Treatment response based on 3-year recurrence-free survival

  Treatment response was defined based on recurrence-free survival (RFS). Patients who developed recurrence within 3 years after curative surgery were classified as non-responders, whereas those without recurrence were classified as responders.

  3 years after surgery

Secondary Outcomes (2)

• Diagnostic performance of the predictive model

  At model evaluation

• Recurrence-free survival stratified by predefined model-derived risk score

  Up to 5 years after surgery

Study Arms (2)

Responder

Patients with stage II/III gastric cancer who did not develop recurrence within 3 years after curative surgery following adjuvant chemotherapy.

Other: Observational study (no intervention)

Non-responder

Patients with stage II/III gastric cancer who developed recurrence within 3 years after curative surgery following adjuvant chemotherapy.

Other: Observational study (no intervention)

Interventions

Observational study (no intervention) OTHER

This is an observational study without assigned interventions. All patients received standard-of-care 5-FU-based adjuvant chemotherapy, and no experimental intervention was performed.

Non-responder; Responder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage II and III gastric cancer who underwent curative resection and received 5-FU-based adjuvant chemotherapy across multiple institutions.

You may qualify if:

• Pathologically confirmed stage II or III gastric cancer
• Underwent curative surgical resection
• Received 5-FU-based adjuvant chemotherapy
• Availability of tumor tissue samples for analysis

You may not qualify if:

• History of other malignancies
• Inadequate or poor-quality tissue samples (e.g., contamination)

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91016, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue samples were used for RNA extraction and alternative splicing analysis

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Ajay Goel

CONTACT

626-256-4673; ajgoel@coh.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)