A Multifactor Prediction Model for Non-curative Outcomes in Mixed-type Early Gastric Cancer

NCT ID: NCT07096947

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 421 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-18
• Study Completion Date: 2025-06-15

Brief Summary

The goal of this dual-center study is to identify the most valuable predictive factors (MVPs) for non-curable mixed-type early gastric cancer (NC-MTEGC) and develop a nomogram scoring model to assist surgeons in formulating precise postoperative combined radiochemotherapy strategies in patients with mixed-type early gastric cancer (MTEGC) who have undergone radical surgical resection. The main question it aims to answer is:

What are the most valuable predictive factors for NC-MTEGC, and can a nomogram scoring model developed based on these factors effectively assist in formulating precise postoperative combined radiochemotherapy strategies?

Patients with MTEGC who have undergone radical surgical resection (including 160 in the training group, 151 in the internal validation set from the First Affiliated Hospital of Nanchang University, and 110 in the external test cohort from the Second Affiliated Hospital of Nanchang University) will be included in the study. The Least Absolute Shrinkage and Selection Operator (LASSO) algorithm will be used to assess key predictive indicators, a nomogram prediction model will be developed based on logistic regression, and an NC-MTEGC risk score model will be constructed. Meanwhile, the model's discriminatory ability, calibration, and clinical utility will be comprehensively validated across the three cohorts, with follow-up for relevant conditions.

Conditions

Mixed-type Early Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

A training set

The patients with early gastric cancer (EGC) who underwent radical gastrectomy at the Donghu Ward of the First Affiliated Hospital of Nanchang University

No interventions assigned to this group

A internal validation set

The patients with early gastric cancer (EGC) who underwent radical gastrectomy at the Xianghu Ward of the First Affiliated Hospital of Nanchang University

No interventions assigned to this group

A external validation set

The patients with early gastric cancer (EGC) who underwent radical gastrectomy of the Second Affiliated Hospital of Nanchang University

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Mixed-type early gastric cancer (MTEGC);

2. Receive a surgical procedure;

3. Complete preoperative data.

Exclusion Criteria

1. Received neoadjuvant therapy;

2. History of gastrectomy;

3. Previous cancer or residual gastric cancer (GC);

4. Distant metastasis at diagnosis;

5. Incomplete preoperative data;

6. Undifferentiated MTEGC components;

7. Missing imaging data or refusal of follow-up.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Lu Han

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The first affiliated hospital of Nanchang University

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

82360112

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024A0032

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FirstNanchangU-97696617

Identifier Type: -

Identifier Source: org_study_id