Skip to main content
OpenTrials
Completed

NCT Number: NCT06467591

Prediction Model for Advanced Gastric Cancer in Elderly

This study aims to develop and validate a Nomogram (mCNS) model for predicting long-term survival in elderly patients following curative resection for advanced gastric cancer. The study is a retrospective multi-center analysis involving 924 gastric cancer patients treated at the Department of Gastrointestinal Surgery of the Affiliated Union Hospital of Fujian Medical University between 2009 and 2013, and 512 patients aged 65 and above who underwent gastric resection at the Affiliated Zhongshan Hospital of Dalian University between 2011 and 2018. An online prognostic tool is introduced to assist clinicians in predicting patient prognosis and customizing treatment and follow-up strategies.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastric Surgery, Fujian Medical University Union Hospital

Fuzhou, Fujian, China

About this study

Data were collected from 1436 gastric cancer patients, of which 555 elderly patients with advanced gastric cancer were ultimately included after applying exclusion criteria. Patients were divided into training and testing cohorts from the Fujian Medical University Affiliated Union Hospital and Dalian University Affiliated Zhongshan Hospital. The study was approved by the institutional review boards with a waiver of informed consent due to the use of anonymized secondary data. The analysis utilized the Cox proportional hazards model to select key variables for predicting overall survival (OS). The study also implemented rigorous data handling procedures, including multiple imputations for missing data. The development of an online prognostic tool based on the Nomogram model is part of the project, designed to provide real-time survival predictions through a user-friendly interface for clinical application.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed as primary gastric adenocarcinoma by preoperative gastric endoscopy pathology;
  • Underwent R0 laparoscopic radical gastrectomy for gastric cancer;
  • Pathological stage T2-4a-N+;
  • Age ≥ 65 years.

Exclusion criteria

  • Pathological stage T1 and T2N0;
  • Age < 65 years;
  • Presence of peritoneal or distant metastasis confirmed before or during surgery;
  • Received neoadjuvant chemotherapy before surgery;
  • Remnant gastric cancer;
  • Emergency surgery or palliative exploratory surgery;
  • Preoperative abdominal CT scan not available or preoperative examination time > 1 month;
  • Survival time less than 1 month;
  • Incomplete clinical and pathological data.

Treatment and study plan

Primary outcomes

  1. 5-Year Overall Survival

    Time frame: 5 years or 60 months.

    The proportion of patients who are alive at five years after treatment for elderly gastric cancer patients.

Secondary outcomes

  1. 3-Year Overall Survival

    Time frame: 3 years or 36 months.

    The proportion of patients who have survived without any signs or symptoms of gastric cancer for 3 years after the initial treatment.

  2. 1-Year Overall Survival

    Time frame: 1 years or 12 months.

    The proportion of patients who have survived without any signs or symptoms of gastric cancer for 1 years after the initial treatment.

Sponsors and collaborators

Lead sponsor

Chang-Ming Huang, Prof.

Other

Registry information

Official study title

Prediction of Long-term Survival and Chemotherapy Benefit in Elderly Advanced Gastric Cancer Patients Based on the mCNS Model of Nutritional Control State Score and Sarcopenia.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2024
Registry last updated
Jun 21, 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.

Published trials that share one or more normalized conditions with this study.