- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06302881
Differentiating Tumor-stroma Ratio in Pancreatic Ductal Adenocarcinoma
March 7, 2024 updated by: Liao Hongfan, First Affiliated Hospital of Chongqing Medical University
One Novel Transfer Learning-based CLIP Model Combined With Self-attention Mechanism for Differentiating the Tumor-stroma Ratio in Pancreatic Ductal Adenocarcinoma: a Multi-center Retrospective Cohort Study
This study introduces a novel transfer learning-based contrastive language-image pretraining adapter (CLIP-adapter) model for predicting the tumor-stroma ratio (TSR) in pancreatic ductal adenocarcinoma (PDAC) using preoperative dual-phase CT images.
The primary aim is to develop an efficient and accessible tool for risk stratification and personalized treatment planning.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
The proposed novel Contrastive Language-Image Pretraining-Adapter (CLIP-adapter) model, leveraging transfer learning, framing CLIP and a self-attention mechanism for predicting TSR in PDAC, in order to exhibit high performance in distinguishing low and high TSR PDAC in the test cohort.
We speculated the CLIP-adapter model outperformed single-phase models, specifically CLIP models based on arterial or venous phase images alone.
The addition of a feature fusion module could enhance the model's differentiation capacity, emphasizing its superiority over single-phase models.
Besides, the model we designed utilized both image and text information during network training, instead of focusing on images only.
This underscores the importance of comprehensive assessment in PDAC imaging evaluation, with the potential to contribute to risk stratification and personalized treatment planning.
Study Type
Observational
Enrollment (Actual)
207
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
A total of 207 patients were chosen from three independent4 hospitals: the First Affiliated Hospital of Chongqing Medical University (FAHCQMU), Daping Hospital of Army Medical University (DPHAMU), and the Third Affiliated Hospital of Chongqing Medical University (TAHCQMU).
Description
Inclusion Criteria:
- patients with pathologically proven PDAC by surgical resection
- patients who underwent CT scan within a month before surgery
- observable pancreatic lesions on available images.
Exclusion Criteria:
- any anti-cancer therapy before CT scanning
- conspicuous interference or significant motion distortions found on images
- partial clinical data
- patients with liver metastases or peritoneal carcinomatosis prior to surgical intervention.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
low TSR and high TSR group
The assessment of the tumor-stroma ratio (TSR) entailed measuring the percentage of tumor and stroma constituents.
Based on earlier research, 5/5 was deemed as ideal threshold of TSR measurement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The diagnostic AUC value of pancreatic ductal adenocarcinoma with deep learning algorithm.
Time Frame: 1 year
|
AUC=(Sensitivity+Specificity)-1
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The diagnostic accuracy of pancreatic ductal adenocarcinoma with deep learning algorithm.
Time Frame: 1 year
|
The diagnostic accuracy of pancreatic ductal adenocarcinoma with deep learning algorithm.
|
1 year
|
|
The diagnostic sensitivity of pancreatic ductal adenocarcinoma with deep learning algorithm.
Time Frame: 1 year
|
The diagnostic sensitivity of pancreatic ductal adenocarcinoma with deep learning algorithm.
|
1 year
|
|
The diagnostic specificity of pancreatic ductal adenocarcinoma with deep learning algorithm.
Time Frame: 1 year
|
The diagnostic specificity of pancreatic ductal adenocarcinoma with deep learning algorithm.
|
1 year
|
|
The diagnostic positive predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm.
Time Frame: 1 year
|
The diagnostic positive predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm.
|
1 year
|
|
The diagnostic negative predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm.
Time Frame: 1 year
|
The diagnostic negative predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
July 1, 2022
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
February 29, 2024
First Submitted That Met QC Criteria
March 7, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- liaohongfan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.