Model for Prognosis of Elderly Gastric Cancer Patients

NCT06393153 | Completed DMC

• 1 other identifier: 2024KY074
• Study Type: observational
• Target: 1,202
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop and validate a Random Survival Forest (RSF) model for predicting long-term survival in elderly patients following curative resection for gastric cancer. The study is a retrospective multi-center analysis involving patients aged 75 and above who underwent gastric resection from January 2009 to December 2018 at nine top-tier hospitals in China. An online prognostic tool is introduced to assist clinicians in predicting patient prognosis and customizing treatment and follow-up strategies.

Conditions

Stomach Neoplasms; Aged

Keywords

Stomach Neoplasms; Prognosis; Elderly; Prediction Model

Outcome Measures

Primary Outcomes (2)

• 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.

• 5-Year Disease-Free Survival

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

  5 years or 60 months.

Secondary Outcomes (4)

• 3-Year Overall Survival

  3 years or 36 months.

• 1-Year Overall Survival

  1 years or 12 months.

• 3-Year Disease-Free Survival

  3 years or 36 months.

• 1-Year Disease-Free Survival

  1 years or 12 months.

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises elderly patients, aged 75 and above, diagnosed with gastric cancer and who underwent curative gastrectomy within a ten-year period from January 2009 to December 2018. The participants were selected from nine major tertiary care centers across China, ensuring a comprehensive representation of the demographic. The selection criteria were strictly adhered to, ensuring a uniform and high-quality dataset for subsequent analysis in developing a robust prognostic model. The study's focus on the elderly demographic addresses a significant gap in prognostic tools for this age group, which often presents with distinct clinical and therapeutic challenges.

You may qualify if:

• Patients aged 75 years or older.
• Histologically confirmed diagnosis of gastric cancer.
• Patients who have undergone curative gastrectomy.

You may not qualify if:

• Patients with non-primary gastric malignancies.
• Pathological confirmation of metastatic disease (M1).
• Incomplete follow-up data or loss to follow-up.

Sponsors & Collaborators

• Chang-Ming Huang, Prof.: lead

Study Sites (1)

Department of Gastric Surgery， Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Chang-Ming Huang, M.D

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: January 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: April 20, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

CN (1)