Combination of CT and Ultrasound Radiomics Combined With Liquid Biopsy to Predict Neoadjuvant Chemotherapy Response in Patients With Locally Advanced Gastric Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorLiu Yang

About this trial

This prospective cohort study aims to construct an artificial intelligence (AI)-derived predictive model for neoadjuvant chemotherapy response prediction in patients with locally advanced gastric cancer based on preoperative ultrasound (US), computed tomography (CT) images and liquid biopsy. Additionally, we explore the potential biological mechanisms behind this model.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of understanding the study and voluntarily signing the written informed consent form (ICF) prior to any study-specified research procedures.

Aged ≥18 and ≤80 years old at the time of ICF signing.

Pathologically confirmed locally advanced gastric cancer (LAGC, cT2NxM0-cT4NxM0) with clinical indications for neoadjuvant chemotherapy.

Completion of gastrointestinal contrast-enhanced ultrasound and contrast-enhanced abdominal CT before neoadjuvant chemotherapy.

Disqualifiers

Diagnosis of non-primary gastric cancer.

Incomplete imaging data, failure to collect peripheral blood samples, or substandard sample quality.

Discontinued chemotherapy, modified treatment regimen, or lack of complete postoperative pathological assessment.

Unavailable follow-up data precluding evaluation of chemotherapy response.

Trial population

patients with histologically confirmed GC at a locally advanced stage (cT2-4N0/+M0) who received NACT

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Good pathological response
Group B: Poor pathological response

Trial outcomes

Primary outcomes

1

Accuracy of pathological response to neoadjuvant chemotherapyin patients with locally advanced gastric cancer models

This prospective study will collect contrast-enhanced abdominal CT and ultrasound images, as well as peripheral blood samples, from 300 patients with locally advanced gastric cancer (LAGC) prior to neoadjuvant chemotherapy. Using deep learning and machine learning algorithms, we will construct a tumor regression grade (TRG)-oriented model to predict pathological response to treatment. TRG classification is defined in accordance with the NCCN Guidelines (Version 4, 2021): TRG 0-1 indicates favorable response; TRG 2-3 poor response. The diagnostic accuracy and stability of the model will be evaluated, with performance quantified via the AUC and precision-recall curve.

Time frame
The pathological response prediction model will be assessed immediately after its development.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liu Yang

Lead sponsor

Qianfoshan Hospital

Sponsor institution

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