Development and Validation of the Surgical Assessment and Healthcare (SAH) Index for Gastric Cancer Treatment Evaluation

NCT07180966 | Active Not Recruiting DMC

• 2 other identifiers: SAH-INDEX2025-594
• Study Type: observational
• Target: 780
• Locations: 1 country
• Sites: 1

Brief Summary

This study develops the Surgical Assessment and Healthcare (SAH) Index, a new tool to fairly evaluate gastric cancer surgery outcomes. Gastric cancer is a serious disease that often requires major surgery, but it can be difficult to compare how well different hospitals or surgeons perform because patients have different levels of risk before surgery. The SAH Index will help solve this problem by creating a standardized way to account for patient risk factors when evaluating surgical results. The study analyzes data from 780 patients who had gastric cancer surgery in 2019, looking at factors like patient age, tumor characteristics, molecular markers, and surgical outcomes. By combining clinical information (like patient health), pathological details (like tumor type), and molecular features (like genetic markers), the SAH Index will create risk categories that allow fair comparison of surgical outcomes. This tool could help hospitals improve their care, help patients and families understand their treatment options, and help doctors make better treatment decisions. The study uses only existing medical records and does not involve any new treatments or procedures. The goal is to create a practical tool that can be used by hospitals and doctors to better evaluate and improve gastric cancer surgery outcomes.

Conditions

Gastric Cancer (GC)

Keywords

SAH Index; Risk adjustment; Gastric cancer surgery;; Prognostic model; Surgical outcomes;; Molecular biomarkers; HER2; Microsatellite instability; Mismatch repair;; Risk stratification; Quality assessment; Postoperative complications; Overall survival;; TNM staging; Lauren classification; Cox regression; Predictive modeling; Healthcare quality; Surgical evaluation; Risk prediction

Outcome Measures

Primary Outcomes (1)

• Development of SAH Index for Risk-Adjusted Gastric Cancer Surgical Evaluation

  Development and internal validation of the Surgical Assessment and Healthcare (SAH) Index incorporating clinical, pathological, and molecular factors to predict surgical outcomes in gastric cancer patients. Performance assessed by discrimination (C-statistic), calibration (Hosmer-Lemeshow test), and risk stratification accuracy.

  5 years post-surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who underwent surgical resection for gastric adenocarcinoma in 2019. The cohort represents a real-world surgical population with complete clinical, pathological, and molecular characterization including TNM staging, Lauren classification, and biomarker status (HER2, MSI, MMR). Patients span all age groups, tumor stages, and surgical approaches, providing a representative sample for SAH Index development and validation. Long-term follow-up data available for survival and complication analysis. This describes your 780-patient cohort while staying under character limits and highlighting the comprehensive nature of your dataset.

You may qualify if:

• Age: 18 years and older Diagnosis: Histologically confirmed gastric adenocarcinoma Treatment: Underwent surgical resection in 2019 Data availability: Complete clinical, pathological, and molecular marker data Follow-up: Minimum 6 months post-operative follow-up data available

You may not qualify if:

• Histology: Non-adenocarcinoma gastric tumors Surgery type: Emergency surgery or palliative procedures only Data quality: Missing essential clinical, pathological, or molecular data required for SAH Index development Follow-up: Lost to follow-up within 30 days post-surgery

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Microsatellite Instability; Postoperative Complications

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Genomic Instability; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESEARCH SCIENTIST

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: September 12, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)