2024-08-15
2027-08-31
2027-12-31
200000
NCT06528223
Zhejiang University
Zhejiang University
INTERVENTIONAL
Research of the Application of Artificial Intelligence Model "PANDA"
The research objective of this project is to conduct a large-scale and prospective real-world validation of the Pancreatic Cancer Screening Model PANDA, which was developed based on deep learning and plain CT scans in previous studies. This validation will be carried out across different scenarios at the First Affiliated Hospital of Zhejiang University, leveraging clinical big data. The goal is to verify the model's role in suggesting and supplementing the diagnosis of PDAC in clinical practice, thereby laying the groundwork for large-scale opportunistic screening of PDAC.
This study focuses on potential cases of clinically missed PDAC. It aims to evaluate the pancreatic cancer screening model PANDA, based on deep learning and non-enhanced CT scans, in a prospective real-world cohort from multiple clinical scenarios at the First Affiliated Hospital of Zhejiang University. The study will track patients with negative imaging reports but positive PANDA model findings, verifying their pathology through gold standard examinations to assess PANDA's efficacy. It aims to validate the model's utility, applicability, sensitivity, and specificity. Based on these objectives, the study will undertake the following: 1. Utilize PANDA's output to categorize enrolled patients into nonPDAC, PDAC, and normal groups. It will compare these results with imaging findings. Patients identified as PANDA-positive for PDAC but without corresponding imaging evidence of pancreatic lesions, or those with imaging suggesting pancreatic findings but lacking subsequent clinical intervention, will be categorized for follow-up. These patients will be recalled to the hospital for further examination and diagnosis at Zhejiang University's First Affiliated Hospital. For PDAC-positive cases identified during secondary examinations, standard clinical procedures such as MDT will be followed for confirmation of pathology. Patients identified as PDAC-negative during secondary examinations will undergo extensive follow-up for up to two years to determine outcomes, thus validating PANDA's sensitivity and specificity. Patients identified by PANDA as nonPDAC-positive but lacking corresponding pancreatic findings in imaging will undergo a review by hepatobiliary pancreatic surgeons to confirm accuracy. Those reported as normal by PANDA but with imaging suggesting pancreatic abnormalities will undergo secondary review by surgical experts to confirm or rule out false negatives by PANDA. 2. For true positive PDAC cases identified by PANDA, medical records will be collected (tumor marker levels, patient symptoms, resectability grading, TNM staging, etc.) for comparison with corresponding indicators from PDAC patients identified through the Standard Order of Clinic SOC. This aims to validate PANDA's capability in early detection and identification of lesions in pancreatic cancer development.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2024-07-15 | N/A | 2024-07-29 |
2024-07-29 | N/A | 2024-07-30 |
2024-07-30 | N/A | 2024-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: PDAC According to the PANDA output results, those with the highest probability of PDAC among nonPDAC, PDAC, and normal categories are categorized into the PDAC group. | DIAGNOSTIC_TEST: biopsy or operation
|
NO_INTERVENTION: nonPDAC According to the PANDA output results, those with the highest probability of nonPDAC among nonPDAC, PDAC, and normal categories are categorized into the nonPDAC group. | |
NO_INTERVENTION: Normal According to the PANDA output results, those with the highest probability of Normal among nonPDAC, PDAC, and normal categories are categorized into the Normal group. |
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
OS | overall survival | From diagnosis of PDAC to 3 years later |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
TNM stage | Staging of pancreatic cancer | 1 day (evaluate through CT imaging before surgery) |
Resectability grading | Resectability grading of pancreatic cancer | 1 day (evaluate through CT imaging before surgery) |
Tumor markers | Characteristic presence in malignant tumor cells or substances produced abnormally by malignant tumor cells,like CA199 | Immediately after recall |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: Qi Zhang, Associate professor Phone Number: 13819137113 Email: qi.zhang@zju.edu.cn |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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