Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396143
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-29
Brief Title:
Research on Intelligent Screening and Decision-making for Neoadjuvant Therapy in Locally Advanced Gastric Cancer Based on Multi-omics Integration
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
Research on Intelligent Screening and Decision-making for Neoadjuvant Therapy in Locally Advanced Gastric Cancer Based on Multi-omics Integration
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study investigators utilize a radiopathomics integrated Artificial Intelligence AI supportive system to predict tumor response to neoadjuvant chemoradiotherapy nCRT before its administration for patients with locally advanced gastric cancer LAGC By the system the postoperative tumor regression grade TRG of the participants will be identified based on the radiopathomics features extracted from the pre-nCRT Enhanced CT and biopsy images The ability to predict TRG will be validated in this multicenter prospective clinical study
Detailed Description:
This is a multicenter prospective observational clinical study for validation of a radiopathomics artificial intelligence AI system Patients who have been diagnosed with gastric adenocarcinoma by pathology and defined as clinical stage II-IVa without distant metastasis by enhanced CT scan will be enrolled from the Second Affiliated Hospital of Zhejiang University the First Affiliated Hospital of Zhejiang University Shangyu Peoples Hospital of Shaoxing City and Zhejiang Cancer Institute Hospital All participants should adhere to a highly standardized treatment protocol which involves receiving either 2-4 courses of standard neoadjuvant chemotherapy based on 5-FU platinum or 2-4 courses of neoadjuvant chemotherapy based on 5-FU platinum combined with trastuzumab or 2-4 courses of neoadjuvant chemotherapy based on 5-FU platinum combined with anti-PD-L1 therapy Following the neoadjuvant treatment protocol participants will undergo a D2 radical gastrectomy for gastric cancer The enhanced CT and biopsy examination should be completed before the nCRT and the images will be subjected to the manual delineation of the tumor regions of interest ROI by experienced radiologists and pathologists Subsequently the enhanced CT and biopsy images outlined will be used in the radiological pathology AI system to generate predicted responses predicted postoperative TRG grading for individual patients while actual responses confirmed postoperative TRG grading will be diagnosed in surgical resection specimens Through comparisons of the predicted responses and true pathologic responses investigators calculate the prediction accuracy specificity sensitivity as well as the Area Under Curve AUC of Receiver Operating Characteristic ROC curves The aim of this study is to verify the high accuracy and robustness of the radiological pathology AI system in predicting postoperative TRG grading in individuals before nCRT which will promote further precise treatment of locally advanced cancer patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None