Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267690
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2024-02-13
Brief Title:
A CT-based Radiomics Model to Predict Survival-graded Fibrosis in PDAC
Sponsor:
First Affiliated Hospital Sun Yat-Sen University
Organization:
First Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
Development and Validation of a CT-based Radiomics Model to Predict Survival-graded Fibrosis in Pancreatic Ductal Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2024-02
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:
Tumor fibrosis plays an important role in chemotherapy resistance in pancreatic ductal adenocarcinoma PDAC however there remains a contradiction in the prognostic value of fibrosis We aimed to investigate the relationship between tumor fibrosis and survival in patients with PDAC classify patients into high- and low-fibrosis groups and develop and validate a CT-based radiomics model to non-invasively predict fibrosis before treatment
Detailed Description:
This retrospective bicentric study included 295 pretreated patients with PDAC Tumor fibrosis was assessed using the collagen fraction CF Clinical-pathological variables were gathered and radiological features were evaluated by three radiologists in consensus The patients were followed up at 1 3 6 and 9 months postoperatively and every 3-6 months thereafter All follow-up examinations included carbohydrate antigen 19-9 CA 19-9 measurements and imaging contrast-enhanced CT contrast-enhanced MRI ultrasonography or positron emission tomography The overall survival OS and disease-free survival DFS were also recorded Cox regression analysis was used to evaluate the associations of CF with OS and DFS Receiver operating characteristic ROC analyses were used to determine the rounded threshold of CF An integrated model IM was developed by incorporating selected radiomic features and clinical-radiological characteristics The predictive performance was validated in the test cohort Center 2 It was hypothesized that tumor fibrosis could be classified into two survival-graded groups and that the incorporation of radiomics features and clinical-radiological features would help predict the status of fibrosis Thus the association between fibrosis and overall survival OSdisease-free survival DFS was determined and the patients with PDAC were divided into high- and low-CF groups in this study In addition a CT-based radiomics model was developed and validated to non-invasively predict fibrosis before treatment in patients with PDAC from two centers It was hypothesized that the performance of the integrated model would be superior to that of the clinical-radiological model
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