CT Imaging and Clinical Features to Predict Outcomes in Patients With Gastric Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pretreatment CT images of insufficient quality for analysis.

Incomplete clinical data.

Presence of another malignant tumor in addition to gastric cancer.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention (observational study)

    Other intervention

    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.

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Prospective Gastric Cancer Validation Cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
From initiation of treatment until disease progression, death, or last follow-up, assessed up to 12 months

Other outcomes

Sponsors and contacts

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