Pancreatic CancerNCT06528223
Research of the Application of Artificial Intelligence Model "PANDA"
A study testing biopsy or operation in people with Pancreatic Cancer, run by Zhejiang University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- biopsy or operation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200,000 participants
- Where
- 2 sitesChina
- Study dates
- 15 Aug 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The participants have undergone chest and/or abdominal plain CT scans at outpatient, inpatient, or physical examination centers
Who cannot join
- Chest CT scan without pancreatic coverage
- Patients undergoing thoracic/abdominal surgical procedures that affect or alter the anatomical display of the pancreas (esophageal/gastric/pancreatic/vascular/ERCP postoperative, etc.)
- Scanning non-standard examinations, such as significant respiratory motion artifacts
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Research of the Application of Artificial Intelligence Model 'PANDA': A MultiCenter, Prospective Randomized Controlled Clinical Trial
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.
Read the detailed description
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:
- 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.
- 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.
- Conditions
- Pancreatic Cancer
- Being tested
- biopsy or operation
- Keywords
- Artificial intelligence, Pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy or operationDiagnostic test
To obtain a biopsy pathology or surgical pathology according to the clinical process of PDAC.
| Study group | Role | What they receive |
|---|---|---|
| PDAC | Experimental | 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. Receives: Diagnostic Test: biopsy or operation |
| nonPDAC | No intervention | 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. |
| Normal | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
overall survival
Measured: From diagnosis of PDAC to 3 years later
Secondary outcomes (3)
TNM stage
Staging of pancreatic cancer
Measured: 1 day (evaluate through CT imaging before surgery)
Resectability grading
Resectability grading of pancreatic cancer
Measured: 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
Measured: Immediately after recall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start15 Aug 2024 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study divides enrolled patients into three groups based on PANDA's output results: nonPDAC, PDAC, and normal.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528223
- Sponsor's protocol ID
- PANDA-PRO
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of the Application of Artificial Intelligence Model 'PANDA': A MultiCenter, Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06528223
- Acronym / sponsor ID
- PANDA-PRO
- Conditions
- Pancreatic Cancer
- Keywords
- Artificial intelligence, Pancreatic cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study divides enrolled patients into three groups based on PANDA's output results: nonPDAC, PDAC, and normal.
| Arm | Type | Receives |
|---|---|---|
| PDAC | Experimental | Diagnostic Test: biopsy or operationAccording to the PANDA output results, those with the highest probability of PDAC among nonPDAC, PDAC, and normal categories are categorized into the PDAC group. |
| nonPDAC | No intervention | –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. |
| Normal | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The participants have undergone chest and/or abdominal plain CT scans at outpatient, inpatient, or physical examination centers
Key exclusion criteria (3 listed)
- Chest CT scan without pancreatic coverage
- Patients undergoing thoracic/abdominal surgical procedures that affect or alter the anatomical display of the pancreas (esophageal/gastric/pancreatic/vascular/ERCP postoperative, etc.)
- Scanning non-standard examinations, such as significant respiratory motion artifacts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsy or operationTo obtain a biopsy pathology or surgical pathology according to the clinical process of PDAC. | Diagnostic test | PDAC |
Primary outcome
OS
Time frame: From diagnosis of PDAC to 3 years later
overall survival
3 secondary outcomes
TNM stage
Time frame: 1 day (evaluate through CT imaging before surgery)
Resectability grading
Time frame: 1 day (evaluate through CT imaging before surgery)
Tumor markers
Time frame: Immediately after recall
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy or operation in people with Pancreatic Cancer, run by Zhejiang University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Zhang, Associate professor (13819137113, qi.zhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: From diagnosis of PDAC to 3 years later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.