Stomach NeoplasmsNCT06467591
Prediction Model for Advanced Gastric Cancer in Elderly
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 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stomach Neoplasms, Aged
- How many people
- 1,436 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 20 May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population comprises elderly patients, aged 65 and above, diagnosed with gastric cancer and who underwent curative gastrectomy within a ten-year period from January 2009 to December 2018. Participants were selected from two major tertiary care centers in China, ensuring a comprehensive representation of the demographic. Strict adherence to selection criteria ensured the use of a consistent and high-quality dataset for subsequent analysis in developing a robust prognostic model. The study focuses on the elderly demographic, addressing 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
- 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.
Who cannot join
- 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;
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- Preoperative abdominal CT scan not available or preoperative examination time > 1 month;
- Survival time less than 1 month;
- Incomplete clinical and pathological data.
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: 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.
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.
Read the detailed 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.
- 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.
Secondary outcomes (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion20 May 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
- 1,436 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
- NCT06467591
- Sponsor's protocol ID
- 2024KY076
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2024
- Last updated
- 21 Jun 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06467591
- Acronym / sponsor ID
- 2024KY076
- Conditions
- Stomach Neoplasms, Aged
- Keywords
- Stomach Neoplasms, Prognosis, Elderly, Prediction Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,436 participants (actual)
- Lead sponsor
- Chang-Ming Huang, Prof.University, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 21 Jun 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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population comprises elderly patients, aged 65 and above, diagnosed with gastric cancer and who underwent curative gastrectomy within a ten-year period from January 2009 to December 2018. Participants were selected from two major tertiary care centers in China, ensuring a comprehensive representation of the demographic. Strict adherence to selection criteria ensured the use of a consistent and high-quality dataset for subsequent analysis in developing a robust prognostic model. The study focuses on the elderly demographic, addressing a significant gap in prognostic tools for this age group, which often presents with distinct clinical and therapeutic challenges.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
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.
2 secondary outcomes
3-Year Overall Survival
Time frame: 3 years or 36 months.
1-Year Overall 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 21 Jun 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 4 inclusion and 9 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 21 Jun 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.). 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 21 Jun 2024.