Pancreatic DiseaseNCT06824909
Endoscopic Ultrasound-guided Fine-needle Aspiration of Solid Pancreatic Lesions With Rapid Staining of Cytological Smears Followed by Whole Slide Scanning and Artificial Intelligence Diagnosis: A Prospective, Multicenter Study.
An observational study of Pancreatic Disease, run by Ruijin Hospital at 2 sites in China.
Trial summary
The objective of this observational study is to investigate whether the self-developed whole slide scanning and artificial intelligence diagnostic system for pancreatic solid lesion puncture cytopathology (hereinafter referred to as the "Zhiying Shunxi" ROSE-AI diagnostic system) can promptly and accurately diagnose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Disease
- What is being tested?
- ROSE-AI diagnostic system
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 2 sitesChina
- Study dates
- 31 Dec 2024to 30 Jun 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients were obtained due to the necessity for disease treatment and in accordance with routine clinical workflows, and finally were confirmed as pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumors, and non-neoplastic benign lesions.
Who may be able to join
- A dated and signed informed consent form A commitment to abide by the research procedures and cooperate throughout the entire study Subjects aged 18 and above, regardless of gender Diagnosis or suspicion of a solid pancreatic space-occupying lesion based on imaging studies (B-mode ultrasound, CT, or MRI)
Who cannot join
- Unable or refusing to sign the informed consent form Unable to suspend anticoagulation/antiplatelet therapy Pregnant or lactating Having a mental illness or other medical conditions that are unsuitable for undergoing FNA/B biopsy Presence of coagulation disorders (PLT < 50 × 10^3/μl, INR > 1.5) Pancreatic cystic lesions Non-diagnostic EUS-FNA/B specimens Having less than 8 microscopic fields of interest (ROI) in the digital pathology images of the entire Diff-Quik smear slide
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, 2 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Duowu Zou, MD, +8613901617608, zdw_pi@126.com
- Recruiting
Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Taojing Ran, MD, 8615601942397, rantaojing@163.com
About this study
Official title: 内镜超声穿刺胰腺实性占位细胞涂片快速染色后全玻片扫描及人工智能诊断：一项前瞻性、多中心研究
The objective of this observational study is to investigate whether the self-developed whole slide scanning and artificial intelligence diagnostic system for pancreatic solid lesion puncture cytopathology (hereinafter referred to as the "Zhiying Shunxi" ROSE-AI diagnostic system) can promptly and accurately diagnose solid pancreatic lesions (SPLs). The main question it aims to answer is:
By utilizing optical imaging technology to capture RGB images of Diff-Quik stained smears from pancreatic punctures, can the development of artificial intelligence algorithms assist in differentiating solid pancreatic space-occupying diseases (such as pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumors, and non-neoplastic benign lesions)?
Researchers will compare the diagnoses of SPLs made by the ROSE-AI system with the actual pathological diagnoses of the SPLs themselves to determine whether the ROSE-AI system can effectively diagnose SPLs.
- Conditions
- Pancreatic Disease
- Being tested
- ROSE-AI diagnostic system
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSE-AI diagnostic systemDevice
All samples were obtained due to the necessity for disease treatment and in accordance with routine clinical workflows. After the pathological diagnoses were confirmed by the pathology departments of the hospitals affiliated with the respective endoscopic centers, the eligible pancreatic puncture Diff-Quik stained smears were borrowed and transferred to Ruijin Hospital Affiliated to School of Medicine, Shanghai Jiao Tong University. There, the self-developed "Zhiying Shunxi" system was used to capture corresponding traditional light microscope RGB images. After the imaging was completed, all specimens were returned to the endoscopic centers from which they originated. Using the RGB images as input, an artificial intelligence algorithm was developed to assist in differentiating solid pancreatic lesions.
| Study group | Role | What they receive |
|---|---|---|
| pancreatic ductal adenocarcinoma | Not described Receives: Device: ROSE-AI diagnostic system | |
| pancreatic neuroendocrine tumor | Not described Receives: Device: ROSE-AI diagnostic system | |
| non-neoplastic benign lesions | Not described Receives: Device: ROSE-AI diagnostic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Accuracy = (TP + TN) / (TP + FP + FN + TN)
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start31 Dec 2024
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Soochow University, Fudan University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The Third Xiangya Hospital of Central South University, Shanghai 10th People's Hospital, Affiliated Hospital of Jiangnan University, Jiangyin People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824909
- Sponsor's protocol ID
- RuijinH2024574
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 内镜超声穿刺胰腺实性占位细胞涂片快速染色后全玻片扫描及人工智能诊断：一项前瞻性、多中心研究
- ClinicalTrials.gov ID
- NCT06824909
- Acronym / sponsor ID
- RuijinH2024574
- Conditions
- Pancreatic Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Soochow University, Fudan University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The Third Xiangya Hospital of Central South University, Shanghai 10th People's Hospital, Affiliated Hospital of Jiangnan University, Jiangyin People's Hospital
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Feb 2025 (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 objective of this observational study is to investigate whether the self-developed whole slide scanning and artificial intelligence diagnostic system for pancreatic solid lesion puncture cytopathology (hereinafter referred to as the "Zhiying Shunxi" ROSE-AI diagnostic system) can promptly and accurately diagnose solid pancreatic lesions (SPLs). The main question it aims to answer is:
By utilizing optical imaging technology to capture RGB images of Diff-Quik stained smears from pancreatic punctures, can the development of artificial intelligence algorithms assist in differentiating solid pancreatic space-occupying diseases (such as pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumors, and non-neoplastic benign lesions)?
Researchers will compare the diagnoses of SPLs made by the ROSE-AI system with the actual pathological diagnoses of the SPLs themselves to determine whether the ROSE-AI system can effectively diagnose SPLs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pancreatic ductal adenocarcinoma | – | Device: ROSE-AI diagnostic system |
| pancreatic neuroendocrine tumor | – | Device: ROSE-AI diagnostic system |
| non-neoplastic benign lesions | – | Device: ROSE-AI diagnostic system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients were obtained due to the necessity for disease treatment and in accordance with routine clinical workflows, and finally were confirmed as pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumors, and non-neoplastic benign lesions.
Key inclusion criteria (1 listed)
- A dated and signed informed consent form A commitment to abide by the research procedures and cooperate throughout the entire study Subjects aged 18 and above, regardless of gender Diagnosis or suspicion of a solid pancreatic space-occupying lesion based on imaging studies (B-mode ultrasound, CT, or MRI)
Key exclusion criteria (1 listed)
- Unable or refusing to sign the informed consent form Unable to suspend anticoagulation/antiplatelet therapy Pregnant or lactating Having a mental illness or other medical conditions that are unsuitable for undergoing FNA/B biopsy Presence of coagulation disorders (PLT < 50 × 10^3/μl, INR > 1.5) Pancreatic cystic lesions Non-diagnostic EUS-FNA/B specimens Having less than 8 microscopic fields of interest (ROI) in the digital pathology images of the entire Diff-Quik smear slide
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 |
|---|---|---|
| ROSE-AI diagnostic systemAll samples were obtained due to the necessity for disease treatment and in accordance with routine clinical workflows. After the pathological diagnoses were confirmed by the pathology departments of the hospitals affiliated with the respective endoscopic centers, the eligible pancreatic puncture Diff-Quik stained smears were borrowed and transferred to Ruijin Hospital Affiliated to School of Medicine, Shanghai Jiao Tong University. There, the self-developed "Zhiying Shunxi" system was used to capture corresponding traditional light microscope RGB images. After the imaging was completed, all specimens were returned to the endoscopic centers from which they originated. Using the RGB images as input, an artificial intelligence algorithm was developed to assist in differentiating solid pancreatic lesions. | Device | non-neoplastic benign lesions, pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumor |
Primary outcome
Accuracy
Time frame: through study completion, an average of 2 years
Accuracy = (TP + TN) / (TP + FP + FN + TN)
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 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Disease, run by Ruijin Hospital 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 1 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: looking for participants now, as of the sponsor's last update on 13 Feb 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: through study completion, an average of 2 years). 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 13 Feb 2025.