Gastric CancerNCT07776067
CT Imaging and Clinical Features to Predict Outcomes in Patients With Gastric Cancer
An observational study of Gastric Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The goal of this prospective observational study is to evaluate how well a previously developed prediction model can estimate outcomes in adults with gastric cancer. The model combines information from computed tomography (CT) images obtained before treatment with routine clinical information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Apr 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients with newly diagnosed gastric cancer who receive treatment at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Eligible patients with available pretreatment CT imaging and relevant clinical data will be prospectively enrolled and followed for clinical outcomes.
Who may be able to join
- Histologically or pathologically confirmed gastric cancer and receiving treatment at the study center.
- Age ≥18 years.
- Complete pretreatment CT imaging data available from the study center.
Who cannot join
- Pretreatment CT images of insufficient quality for analysis.
- Incomplete clinical data.
- Presence of another malignant tumor in addition to gastric cancer.
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Lixia Wang, +86 13886104399, lisa2003627_1@163.com
About this study
Official title: Prospective Validation of a CT Radiomics-Based Model Combined With Clinical Features for Prognosis Prediction in Gastric Cancer Patients
The goal of this prospective observational study is to evaluate how well a previously developed prediction model can estimate outcomes in adults with gastric cancer. The model combines information from computed tomography (CT) images obtained before treatment with routine clinical information. The main questions are how well the model predicts how long participants live after treatment begins and whether their cancer progresses.
Participants will receive their usual medical care. Researchers will collect pretreatment CT images, basic clinical and tumor information, laboratory and tumor marker results, treatment information, and follow-up outcomes obtained during routine care. These data will be entered into the predefined prediction model, and the model's predictions will be compared with what actually happens during follow-up.
The study will not change the participants' usual treatment. Model predictions will be used for research purposes only and will not be used to make treatment decisions.
Read the detailed description
This is a single-center, non-interventional prospective observational cohort study designed to validate a prognostic prediction model for gastric cancer that integrates pretreatment CT imaging features with clinical variables. The model was developed from a previous retrospective cohort of patients with gastric cancer using pretreatment CT images, clinicopathological information, treatment data, and survival outcomes.
Adults with newly diagnosed gastric cancer who are scheduled to receive surgery, chemotherapy, immunotherapy, or combined treatment at the study center will be prospectively enrolled. During routine clinical care, researchers will collect pretreatment CT images and relevant demographic, clinicopathological, laboratory, tumor marker, treatment, and follow-up data. Quantitative CT features related to tumor morphology, density, texture, and spatial heterogeneity will be integrated with clinical variables such as age, sex, TNM stage, Lauren classification, serum tumor markers, and treatment modality to generate individualized prognostic risk estimates.
Model predictions will be compared with observed clinical outcomes during follow-up to evaluate prognostic performance and risk stratification. Model performance will also be assessed in clinically relevant subgroups, including groups defined by treatment modality, clinical stage, age, and sex. Statistical analyses will include Kaplan-Meier survival analysis, log-rank tests, and Cox proportional hazards regression with adjustment for potential confounding factors.
This study will not assign treatment or alter routine clinical care. All treatment decisions will be made by treating clinicians according to each participant's clinical condition and current clinical practice. Model-generated predictions will be stored for research purposes only and will not be provided to clinicians for treatment decision-making. Clinical and imaging data will be coded and de-identified and stored in a password-protected research database. Data quality will be supported by standardized data collection procedures, investigator training, independent data checking, imaging quality review, and standardized follow-up procedures.
- Conditions
- Gastric Cancer
- Being tested
- No intervention (observational study)
- Keywords
- Computed Tomography, Radiomics, Prognostic Model, Overall Survival, Progression-Free Survival, Prospective Validation
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention or treatment will be assigned by the study protocol. All diagnostic and treatment decisions, including surgery, chemotherapy, immunotherapy, or combined treatment, will be made by treating clinicians as part of routine clinical care. The predefined CT radiomics-based prognostic model will be applied to collected imaging and clinical data for research validation only. Model-generated predictions will not be used to guide or modify clinical treatment decisions.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Gastric Cancer Validation Cohort | Adults with newly diagnosed gastric cancer will be prospectively enrolled at the study center. Eligible participants will have pretreatment CT imaging and relevant clinical data available for analysis. Participants will receive routine clinical care according to their clinical condition. Pretreatment CT imaging and clinical data will be analyzed using the predefined prognostic model, and model predictions will be compared with observed clinical outcomes during follow-up. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival is defined as the time from initiation of initial treatment to death from any cause. Participants who are alive at the last available clinical follow-up will be censored at the date of last follow-up. Survival status will be obtained from medical records, telephone follow-up, and death certificates.
Measured: From initiation of treatment until death or last follow-up, assessed up to 12 months
Secondary outcomes (1)
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from initiation of treatment to the first documented disease progression or death from any cause, whichever occurs first. Participants without disease progression or death will be censored at the date of the last available clinical assessment.
Measured: From initiation of treatment until disease progression, death, or last follow-up, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776067
- Sponsor's protocol ID
- RAI-GC-2026-001
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of a CT Radiomics-Based Model Combined With Clinical Features for Prognosis Prediction in Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT07776067
- Acronym / sponsor ID
- RAI-GC-2026-001
- Conditions
- Gastric Cancer
- Keywords
- Computed Tomography, Radiomics, Prognostic Model, Overall Survival, Progression-Free Survival, Prospective Validation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 20 Aug 2026 (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 goal of this prospective observational study is to evaluate how well a previously developed prediction model can estimate outcomes in adults with gastric cancer. The model combines information from computed tomography (CT) images obtained before treatment with routine clinical information. The main questions are how well the model predicts how long participants live after treatment begins and whether their cancer progresses.
Participants will receive their usual medical care. Researchers will collect pretreatment CT images, basic clinical and tumor information, laboratory and tumor marker results, treatment information, and follow-up outcomes obtained during routine care. These data will be entered into the predefined prediction model, and the model's predictions will be compared with what actually happens during follow-up.
The study will not change the participants' usual treatment. Model predictions will be used for research purposes only and will not be used to make treatment decisions.
Detailed description
This is a single-center, non-interventional prospective observational cohort study designed to validate a prognostic prediction model for gastric cancer that integrates pretreatment CT imaging features with clinical variables. The model was developed from a previous retrospective cohort of patients with gastric cancer using pretreatment CT images, clinicopathological information, treatment data, and survival outcomes.
Adults with newly diagnosed gastric cancer who are scheduled to receive surgery, chemotherapy, immunotherapy, or combined treatment at the study center will be prospectively enrolled. During routine clinical care, researchers will collect pretreatment CT images and relevant demographic, clinicopathological, laboratory, tumor marker, treatment, and follow-up data. Quantitative CT features related to tumor morphology, density, texture, and spatial heterogeneity will be integrated with clinical variables such as age, sex, TNM stage, Lauren classification, serum tumor markers, and treatment modality to generate individualized prognostic risk estimates.
Model predictions will be compared with observed clinical outcomes during follow-up to evaluate prognostic performance and risk stratification. Model performance will also be assessed in clinically relevant subgroups, including groups defined by treatment modality, clinical stage, age, and sex. Statistical analyses will include Kaplan-Meier survival analysis, log-rank tests, and Cox proportional hazards regression with adjustment for potential confounding factors.
This study will not assign treatment or alter routine clinical care. All treatment decisions will be made by treating clinicians according to each participant's clinical condition and current clinical practice. Model-generated predictions will be stored for research purposes only and will not be provided to clinicians for treatment decision-making. Clinical and imaging data will be coded and de-identified and stored in a password-protected research database. Data quality will be supported by standardized data collection procedures, investigator training, independent data checking, imaging quality review, and standardized follow-up procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Gastric Cancer Validation Cohort | – | Other: No intervention (observational study)Adults with newly diagnosed gastric cancer will be prospectively enrolled at the study center. Eligible participants will have pretreatment CT imaging and relevant clinical data available for analysis. Participants will receive routine clinical care according to their clinical condition. Pretreatment CT imaging and clinical data will be analyzed using the predefined prognostic model, and model predictions will be compared with observed clinical outcomes during follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients with newly diagnosed gastric cancer who receive treatment at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Eligible patients with available pretreatment CT imaging and relevant clinical data will be prospectively enrolled and followed for clinical outcomes.
Key inclusion criteria (3 listed)
- Histologically or pathologically confirmed gastric cancer and receiving treatment at the study center.
- Age ≥18 years.
- Complete pretreatment CT imaging data available from the study center.
Key exclusion criteria (3 listed)
- Pretreatment CT images of insufficient quality for analysis.
- Incomplete clinical data.
- Presence of another malignant tumor in addition to 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)No intervention or treatment will be assigned by the study protocol. All diagnostic and treatment decisions, including surgery, chemotherapy, immunotherapy, or combined treatment, will be made by treating clinicians as part of routine clinical care. The predefined CT radiomics-based prognostic model will be applied to collected imaging and clinical data for research validation only. Model-generated predictions will not be used to guide or modify clinical treatment decisions. | Other | Prospective Gastric Cancer Validation Cohort |
Primary outcome
Overall Survival (OS)
Time frame: From initiation of treatment until death or last follow-up, assessed up to 12 months
Overall survival is defined as the time from initiation of initial treatment to death from any cause. Participants who are alive at the last available clinical follow-up will be censored at the date of last follow-up. Survival status will be obtained from medical records, telephone follow-up, and death certificates.
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: From initiation of treatment until disease progression, death, or last follow-up, assessed up to 12 months
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 31 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
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 Gastric Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. 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?
Overall Survival (OS) (time frame: From initiation of treatment until death or last follow-up, assessed up to 12 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 31 Aug 2026.