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Completed

NCT Number: NCT07096947

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The first affiliated hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mixed-type early gastric cancer (MTEGC);
  • Receive a surgical procedure;
  • Complete preoperative data.

Exclusion criteria

  • Received neoadjuvant therapy;
  • History of gastrectomy;
  • Previous cancer or residual gastric cancer (GC);
  • Distant metastasis at diagnosis;
  • Incomplete preoperative data;
  • Undifferentiated MTEGC components;
  • Missing imaging data or refusal of follow-up.

Treatment and study plan

Primary outcomes

  1. The incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer

    Time frame: From enrollment to the end of treatment at 5 years

    Evaluate the incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer via the Nomogram model scoring.

Secondary outcomes

  1. Pathological malignancy grade

    Time frame: Periprocedural

    Grading criteria refer to clinical guidelines: High risk, Medium risk, Low risk.

Other outcomes

  1. Lymph node metastasis detected by CT

    Time frame: From enrollment to the end of treatment at 5 years

    The 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)".

  2. Tumor lesion long diameter

    Time frame: Periprocedural

    Measured and reported in millimeters (mm)

  3. Ulcer long diameter

    Time frame: Periprocedural

    Measured and reported in millimeters (mm)

  4. T stage

    Time frame: Periprocedural

    Staging criteria refer to clinical guidelines

  5. Gender

    Time frame: Baseline

    Binary classification, divided into male and female

  6. Ki67 expression level

    Time frame: Periprocedural

    Measured and reported as a percentage (%)

  7. P53 expression level

    Time frame: Periprocedural

    Measured and reported as a percentage (%)

  8. Lesion location

    Time frame: Periprocedural

    The lesion locations are classified as follows: Gastric Body, Gastric Antrum, Gastric Angle, Cardia, Pylorus, and Antrum-Body Junction.

  9. CEA level

    Time frame: Baseline

    Measured and reported in nanograms per milliliter (ng/mL)

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Nanchang University

Other

Registry information

Official study title

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

Acronym: MTEGC

Important dates

Study start
2017
Primary completion
2022
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.