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

A Multifactor Prediction Model for Non-curative Outcomes in Mixed-type Early Gastric Cancer: a Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07096947
Acronym
MTEGC
Enrollment
421
Registered
2025-07-31
Start date
2017-01-18
Completion date
2025-06-15
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mixed-type Early Gastric Cancer

Keywords

Mixed-type Early Gastric Cancer, Non-curative Outcomes, Nomogram Model, Prognosis, Dual-center Retrospective Cohort

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.

Interventions

None listed

Sponsors

The First Affiliated Hospital of Nanchang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancerFrom enrollment to the end of treatment at 5 yearsEvaluate the incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer via the Nomogram model scoring.

Secondary

MeasureTime frameDescription
Pathological malignancy gradePeriproceduralGrading criteria refer to clinical guidelines: High risk, Medium risk, Low risk.

Other

MeasureTime frameDescription
Ulcer long diameterPeriproceduralMeasured and reported in millimeters (mm)
T stagePeriproceduralStaging criteria refer to clinical guidelines
GenderBaselineBinary classification, divided into male and female
Lymph node metastasis detected by CTFrom enrollment to the end of treatment at 5 yearsThe status of lymph node metastasis is divided into no lymph node metastasis (no tumor cell invasion of lymph nodes detected) and lymph node metastasis (the presence of tumor cell invasion of lymph nodes).
P53 expression levelPeriproceduralMeasured and reported as a percentage (%)
Lesion locationPeriproceduralThe lesion locations are classified as follows: Gastric Body, Gastric Antrum, Gastric Angle, Cardia, Pylorus, and Antrum-Body Junction.
CEA levelBaselineMeasured and reported in nanograms per milliliter (ng/mL)
Ki67 expression levelPeriproceduralMeasured and reported as a percentage (%)
Tumor lesion long diameterPeriproceduralMeasured and reported in millimeters (mm)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026