Stomach NeoplasmsNCT06393153
Model for Prognosis of Elderly Gastric Cancer Patients
An observational study of Stomach Neoplasms and Aged, run by Chang-Ming Huang, Prof. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Stomach Neoplasms, Aged
- How many people
- 1,202 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 20 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Patients aged 75 years or older.
- Histologically confirmed diagnosis of gastric cancer.
- Patients who have undergone curative gastrectomy.
Who cannot join
- Patients with non-primary gastric malignancies.
- Pathological confirmation of metastatic disease (M1).
- Incomplete follow-up data or loss to follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastric Surgery， Fujian Medical University Union Hospital
Fuzhou, Fujian
About this study
Official title: Development and Validation of a Machine Learning Model for Predicting the Prognosis of Elderly Gastric Cancer Patients: A Multi-Center Study in China
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.
- Conditions
- Stomach Neoplasms, Aged
- Keywords
- Stomach Neoplasms, Prognosis, Elderly, Prediction Model
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
5-Year Overall Survival
The proportion of patients who are alive at five years after treatment for elderly gastric cancer patients.
Measured: 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.
Measured: 5 years or 60 months.
Secondary outcomes (4)
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.
Measured: 3 years or 36 months.
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.
Measured: 1 years or 12 months.
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.
Measured: 3 years or 36 months.
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.
Measured: 1 years or 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Jan 2024
- Primary completion1 Apr 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang-Ming Huang, Prof.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Chang-Ming Huang, M.D, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393153
- Sponsor's protocol ID
- 2024KY074
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Machine Learning Model for Predicting the Prognosis of Elderly Gastric Cancer Patients: A Multi-Center Study in China
- ClinicalTrials.gov ID
- NCT06393153
- Acronym / sponsor ID
- 2024KY074
- Conditions
- Stomach Neoplasms, Aged
- Keywords
- Stomach Neoplasms, Prognosis, Elderly, Prediction Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,202 participants (actual)
- Lead sponsor
- Chang-Ming Huang, Prof.University, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients aged 75 years or older.
- Histologically confirmed diagnosis of gastric cancer.
- Patients who have undergone curative gastrectomy.
Key exclusion criteria (3 listed)
- Patients with non-primary gastric malignancies.
- Pathological confirmation of metastatic disease (M1).
- Incomplete follow-up data or loss to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5-Year Disease-Free Survival
Time frame: 5 years or 60 months.
The proportion of patients who have survived without any signs or symptoms of gastric cancer for five years after the initial treatment.
4 secondary outcomes
3-Year Overall Survival
Time frame: 3 years or 36 months.
1-Year Overall Survival
Time frame: 1 years or 12 months.
3-Year Disease-Free Survival
Time frame: 3 years or 36 months.
1-Year Disease-Free Survival
Time frame: 1 years or 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Ming Huang, M.D principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms and Aged, run by Chang-Ming Huang, Prof. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-Year Overall Survival (time frame: 5 years or 60 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.