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CompletedNCT06393153Updated May 1, 2024

Model for Prognosis of Elderly Gastric Cancer Patients

An observational study in Stomach Neoplasms and Aged, sponsored by Chang-Ming Huang, Prof.. Completed at 1 site in China. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2024-05-01.

Sponsored by Chang-Ming Huang, Prof. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,202
Ages
75 Years and older
Sex
All
01

Study 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.

Read the detailed description

This retrospective multi-center study focuses on the development and validation of a predictive model for elderly gastric cancer patients. Data were collected from 16,344 gastric cancer patients, with 1,202 elderly patients ultimately included after applying exclusion criteria. Patients were randomly divided into training and testing cohorts in a 7:3 ratio. 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 employs the Random Survival Forest (RSF) method, incorporating variable importance and minimal depth techniques to select key variables for predicting overall survival (OS) and disease-free survival (DFS). The study also implements rigorous data handling procedures, including multiple imputations for missing data.

The development of an online prognostic tool based on the RSF model is part of the project, designed to provide real-time survival predictions through a user-friendly interface for clinical application.

02

Conditions studied

  • Stomach Neoplasms
  • Aged

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Keywords

  • Stomach Neoplasms
  • Prognosis
  • Elderly
  • Prediction Model
03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's enrollment of 1,202 is above the median of 281 across 684 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Chang-Ming Huang, Prof. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with non-primary gastric malignancies.
  • Pathological confirmation of metastatic disease (M1).
  • Incomplete follow-up data or loss to follow-up.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,202 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 5-Year Overall Survival

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

    Time frame: 5 years or 60 months.

  2. 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.

    Time frame: 5 years or 60 months.

Secondary outcomes

  1. 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.

    Time frame: 3 years or 36 months.

  2. 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.

    Time frame: 1 years or 12 months.

  3. 3-Year Disease-Free Survival

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

    Time frame: 3 years or 36 months.

  4. 1-Year Disease-Free Survival

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

    Time frame: 1 years or 12 months.

07

Study locations

1 site
  • Department of Gastric Surgery, Fujian Medical University Union Hospital
    Fuzhou, Fujian, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2024 to primary completion in Apr 2024, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2024
First posted
May 1, 2024
StartActual
Jan 1, 2024
Primary completionActual
Apr 1, 2024
CompletionActual
Apr 20, 2024
Last update
May 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06393153
Lead sponsor
Chang-Ming Huang, Prof.
Responsible party
Chang-Ming Huang, Prof. (Professor, Fujian Medical University) — Sponsor-investigator
First posted
May 1, 2024
Start date
Jan 1, 2024
Primary completion
Apr 1, 2024
Completion
Apr 20, 2024
Last update
May 1, 2024

Study contacts

Chang-Ming Huang, M.D
principal investigator · Fujian Medical University Union Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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