The Primary Focus of This Study is on Gastric CancerNCT06534814
Development and Application of an Artificial Intelligence-driven Accurate Identification Model for Gastric Cancer Lymph Node Metastasis
An observational study of The Primary Focus of This Study is on Gastric Cancer, run by Hebei Medical University at 1 site in China.
Trial summary
The clinical trial titled "Development and Application of an Artificial Intelligence-Driven Accurate Identification Model for Gastric Cancer Lymph Node Metastasis" aims to enhance the detection and treatment of gastric cancer through the utilization of cutting-edge artificial intelligence (AI) technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Primary Focus of This Study is on Gastric Cancer
- What is being tested?
- AI-Driven Identification Model for Gastric Cancer Lymph Node Metastasis (AID-GLNM)
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population for the clinical trial titled "Development and Application of an Artificial Intelligence-Driven Accurate Identification Model for Gastric Cancer Lymph Node Metastasis (AID-GLNM)" will consist of patients diagnosed with gastric cancer, with a focus on those exhibiting lymph node involvement.
Who may be able to join
- Diagnosis of Gastric Cancer: Confirmed diagnosis of gastric cancer, either newly diagnosed or recurrent.
- Lymph Node Involvement: Suspected or confirmed involvement of lymph nodes, as indicated by imaging studies or pathology reports.
- Age: Patients aged 18 years or older.
- Performance Status: An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, indicating a functional status that allows participation in the study.
- Informed Consent: Ability to provide written informed consent to participate in the study.
Who cannot join
- Pregnancy or Lactation: Pregnant or lactating women, due to potential risks to the fetus or infant.
- Severe Comorbid Conditions: Presence of severe comorbid medical conditions that could interfere with the study or pose additional risks.
- Previous AI-Driven Diagnostic Intervention: Prior use of any AI-driven diagnostic models specifically for gastric cancer lymph node metastasis.
- Inability to Comply: Inability or unwillingness to comply with study procedures, including follow-up visits and data collection.
- Mental or Cognitive Impairment: Conditions that impair the ability to provide informed consent or participate effectively in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery
Shijiazhuang, Hebei, 050011
Ping'an Ding, 031186095363, ding_ping_an@hebmu.edu.cn
Qun Zhao, Doctor
About this study
Official title: Hebei Medical University
The clinical trial titled "Development and Application of an Artificial Intelligence-Driven Accurate Identification Model for Gastric Cancer Lymph Node Metastasis" aims to enhance the detection and treatment of gastric cancer through the utilization of cutting-edge artificial intelligence (AI) technology. This study will develop an AI-driven model designed to accurately identify lymph node metastasis in patients with gastric cancer, which is crucial for staging the disease and planning effective treatment strategies.
The trial will involve a multidisciplinary team of oncologists, radiologists, data scientists, and AI experts who will collaborate to create a robust and precise identification system. Participants will undergo standard diagnostic procedures, and the AI model will analyze imaging and pathological data to predict lymph node involvement.
By comparing the AI model's predictions with traditional diagnostic methods, the study seeks to validate the model's accuracy and efficiency. This approach is expected to improve early detection rates, reduce diagnostic errors, and ultimately lead to better clinical outcomes for patients with gastric cancer. The successful implementation of this AI-driven model could revolutionize the current standards of care and serve as a blueprint for integrating AI technologies in other cancer diagnoses and treatments.
- Being tested
- AI-Driven Identification Model for Gastric Cancer Lymph Node Metastasis (AID-GLNM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Driven Identification Model for Gastric Cancer Lymph Node Metastasis (AID-GLNM)Diagnostic test
The AI-Driven Identification Model for Gastric Cancer Lymph Node Metastasis (AID-GLNM) intervention involves the development and application of an advanced artificial intelligence (AI) system specifically designed to enhance the identification and characterization of lymph node metastasis in patients diagnosed with gastric cancer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of metastatic lymph nodes
A prediction model based on artificial intelligence technology was constructed to accurately identify metastatic perigastric lymph nodes before surgery.
Measured: 2025-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Primary Focus of This Study is on Gastric CancerStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qun Zhao, Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534814
- Sponsor's protocol ID
- FUTURE08
- Status last verified
- Aug 2024
- First submitted
- 25 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hebei Medical University
- ClinicalTrials.gov ID
- NCT06534814
- Acronym / sponsor ID
- FUTURE08
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 2 Aug 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.
The clinical trial titled "Development and Application of an Artificial Intelligence-Driven Accurate Identification Model for Gastric Cancer Lymph Node Metastasis" aims to enhance the detection and treatment of gastric cancer through the utilization of cutting-edge artificial intelligence (AI) technology. This study will develop an AI-driven model designed to accurately identify lymph node metastasis in patients with gastric cancer, which is crucial for staging the disease and planning effective treatment strategies.
The trial will involve a multidisciplinary team of oncologists, radiologists, data scientists, and AI experts who will collaborate to create a robust and precise identification system. Participants will undergo standard diagnostic procedures, and the AI model will analyze imaging and pathological data to predict lymph node involvement.
By comparing the AI model's predictions with traditional diagnostic methods, the study seeks to validate the model's accuracy and efficiency. This approach is expected to improve early detection rates, reduce diagnostic errors, and ultimately lead to better clinical outcomes for patients with gastric cancer. The successful implementation of this AI-driven model could revolutionize the current standards of care and serve as a blueprint for integrating AI technologies in other cancer diagnoses and treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population for the clinical trial titled "Development and Application of an Artificial Intelligence-Driven Accurate Identification Model for Gastric Cancer Lymph Node Metastasis (AID-GLNM)" will consist of patients diagnosed with gastric cancer, with a focus on those exhibiting lymph node involvement.
Key inclusion criteria (5 listed)
- Diagnosis of Gastric Cancer: Confirmed diagnosis of gastric cancer, either newly diagnosed or recurrent.
- Lymph Node Involvement: Suspected or confirmed involvement of lymph nodes, as indicated by imaging studies or pathology reports.
- Age: Patients aged 18 years or older.
- Performance Status: An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, indicating a functional status that allows participation in the study.
- Informed Consent: Ability to provide written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Pregnancy or Lactation: Pregnant or lactating women, due to potential risks to the fetus or infant.
- Severe Comorbid Conditions: Presence of severe comorbid medical conditions that could interfere with the study or pose additional risks.
- Previous AI-Driven Diagnostic Intervention: Prior use of any AI-driven diagnostic models specifically for gastric cancer lymph node metastasis.
- Inability to Comply: Inability or unwillingness to comply with study procedures, including follow-up visits and data collection.
- Mental or Cognitive Impairment: Conditions that impair the ability to provide informed consent or participate effectively in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Driven Identification Model for Gastric Cancer Lymph Node Metastasis (AID-GLNM)The AI-Driven Identification Model for Gastric Cancer Lymph Node Metastasis (AID-GLNM) intervention involves the development and application of an advanced artificial intelligence (AI) system specifically designed to enhance the identification and characterization of lymph node metastasis in patients diagnosed with gastric cancer. | Diagnostic test | – |
Primary outcome
Identification of metastatic lymph nodes
Time frame: 2025-12-31
A prediction model based on artificial intelligence technology was constructed to accurately identify metastatic perigastric lymph nodes before surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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.
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 The Primary Focus of This Study is on Gastric Cancer, run by Hebei Medical University 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of metastatic lymph nodes (time frame: 2025-12-31). 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 2 Aug 2024; AzTrials last refreshed its copy on 29 Oct 2026.