Prediction Model for Advanced Gastric Cancer in Elderly

Stomach Neoplasms Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06467591
• Other study ID #: 2024KY076
• Status: Completed
• Start date: January 1, 2024
• Est. completion date: May 20, 2024

Study information

• Verified date: June 2024
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1436
• Est. completion date: May 20, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aged
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Department of Gastric Surgery, Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Chang-Ming Huang, Prof.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-Year Overall Survival	The proportion of patients who are alive at five years after treatment for elderly gastric cancer patients.	5 years or 60 months.
Secondary	3-Year Overall Survival	The proportion of patients who have survived without any signs or symptoms of gastric cancer for 3 years after the initial treatment.	3 years or 36 months.
Secondary	1-Year Overall Survival	The proportion of patients who have survived without any signs or symptoms of gastric cancer for 1 years after the initial treatment.	1 years or 12 months.