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Completed

NCT Number: NCT06548464

Interpretable Machine Learning Models for Prognosis in Gastric Cancer Patients

This multicenter, retrospective cohort study aimed to develop and validate an explainable prediction model for prognosis after gastrectomy in patients with gastric cancer.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang-ming Huang

Fuzhou, Fujian, 350001, China

About this study

This multicenter, retrospective cohort study aimed to develop and validate an explainable prediction model for prognosis after gastrectomy in patients with gastric cancer. The study included patients who underwent radical gastrectomy for primary gastric or gastroesophageal junction cancer across multiple institutions in China.

The primary objective was to create a machine learning-based model to predict postoperative outcomes following gastrectomy, using readily available clinical and pathological parameters. The main outcome of interest was early recurrence within 2 years after surgery, which significantly impacts overall prognosis.

The study employed various machine learning algorithms to develop prediction models, which were then compared and validated. Model performance was assessed through measures such as area under the receiver operating characteristic curve (AUC), calibration, and Brier score. The SHapley Additive exPlanations (SHAP) method was used to interpret the model and rank feature importance.

This research aims to provide clinicians with a tool for identifying patients at higher risk of poor postoperative outcomes who may benefit from more intensive post-operative monitoring and early intervention strategies, potentially improving prognosis for gastric cancer patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with primary gastric or gastroesophageal junction cancer
  • Underwent radical gastrectomy
  • Complete clinical and pathological data available

Exclusion criteria

  • Presence of distant metastases before surgery
  • Non-adenocarcinoma histology
  • Incomplete follow-up data

Treatment and study plan

Primary outcomes

  1. Survival

    Time frame: Up to 5 years after surgery

    Assessment of overall survival outcomes in gastric cancer patients after gastrectomy.

Secondary outcomes

  1. Early Recurrence

    Time frame: Within 2 years after surgery

    Incidence of cancer recurrence within 2 years after gastrectomy.

  2. Late Recurrence

    Time frame: From 2 years up to 5 years after surgery

    Incidence of cancer recurrence occurring more than 2 years after gastrectomy.

  3. Postoperative Complications

    Time frame: Within 30 days after surgery

    Incidence and severity of complications following gastrectomy.

  4. Neoadjuvant Treatment Efficacy

    Time frame: From initiation of neoadjuvant therapy to surgery (typically 2-3 months)

    Assessment of tumor response to neoadjuvant therapy before gastrectomy.

  5. 5-Year Survival Rate

    Time frame: 5 years after surgery

    Percentage of patients alive 5 years after gastrectomy.

Sponsors and collaborators

Lead sponsor

Chang-Ming Huang, Prof.

Other

Registry information

Official study title

Development and Validation of Interpretable Machine Learning Models for Prognosis in Gastric Cancer Patients: a Multicenter Retrospective Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

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.

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