The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph NodeROSE，EUS-FNANCT06718725
An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study.
An observational study of The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This is an observational study with a prospective, multicenter, disgnostic design. An artificial intelligence system named ROSE-AI system was developed using cytopathological slide images taken by microscope camera or smartphone of pancreas, bile duct, liver and lymph node, collected retrospectively from patients who… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node
- What is being tested?
- ROSE-AI system
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to Apr 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with pancreatic, bile duct, hepatic, or lymph node lesions undergoing EUS-FNA and ROSE from the participating hospitals.
Who may be able to join
- the patient age ≥18 years accepted EUS-FNA+ROSE.
- agree to participate in the research and be able to sign written informed consent.
Who cannot join
- uncorrectable coagulopathy (PTT >50 seconds or INR >1.5) and/or uncorrectable thrombocytopenia (platelet count <50 × 109 /L).
- patients who were too clinically ill to undergo an EUS examination.
- lesions that were deemed inaccessible for EUS-guided sampling.
- unsuccessful EUS-FNA (e.g., failure to obtain an adequate specimen, patient intolerance, intraoperative accidents, etc.).
- Patients with unqualified ROSE smear.
- Patients who underwent biopsy during EUS-FNA but did not receive a definitive pathological diagnosis or pathological report.
- pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
About this study
Official title: An Artificial Intelligence System for Rapid Onsite Cytologic Pathology Evaluation（ROSE） of Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) Sample: a Prospective, Multicenter, Diagnostic Study.
This is an observational study with a prospective, multicenter, disgnostic design. An artificial intelligence system named ROSE-AI system was developed using cytopathological slide images taken by microscope camera or smartphone of pancreas, bile duct, liver and lymph node, collected retrospectively from patients who underwent EUS-FNA and ROSE, and the performance of ROSE-AI system was validated in the datasets collected prospectively.This study aims to assist endoscopists in conducting rapid on-site cytopathology evaluations during EUS-FNA without the presence of cytopathologists. In addition, the diagnostic field was compared between the cytopathologists and ROSE-AI system, endoscopists with or without ROSE-AI system.
- Conditions
- The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node
- Being tested
- ROSE-AI system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSE-AI systemDiagnostic test
The cytopathological slide images of the patients' ROSE samples will be identified by the ROSE-AI system.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing EUS-FNA and ROSE | Patients ≥18 years with pancreatic, bile duct, hepatic, or lymph node lesions accepted EUS-FNA and ROSE. Receives: Diagnostic Test: ROSE-AI system |
What is being measured
The primary outcome is the main question the study is designed to answer.
the accuracy, sensitivity and specificity of the ROSE-AI system in identifying malignant/non-malignant ROSE samples
The primary outcome of the study is to evaluate the performance of the ROSE-AI system in identifying the malignant/non-malignant ROSE samples of pancreatic, bile duct, hepatic and lymph node based on both images taken by microscope camera and smartphone, and comparing the performance between the ROSE-AI system and endoscopists, cytopathologists.
Measured: During procedure
Secondary outcomes (1)
comparing the diagnostic performance between endoscopists with ROSE-AI system and without ROSE-AI system
A cross-over human-AI contest using images of the prospective testing dataset will be performed. The diagnostic performance of endoscopists with ROSE-AI system and without ROSE-AI system will be evaluated.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Sep 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph NodeStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 236 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Taian City Central Hospital, Qilu Hospital of Shandong University (Qingdao), Shandong Provincial Hospital, Liaocheng People's Hospital, The Affiliated Hospital of Qingdao University, Binzhou People's Hospital, Binzhou Medical University, 960th Hospital of PLA, Weifang Yidu Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718725
- Sponsor's protocol ID
- 2024SDU-QILU-1
- Acronym
- ROSE，EUS-FNA
- Status last verified
- Sep 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Artificial Intelligence System for Rapid Onsite Cytologic Pathology Evaluation（ROSE） of Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) Sample: a Prospective, Multicenter, Diagnostic Study.
- ClinicalTrials.gov ID
- NCT06718725
- Acronym / sponsor ID
- ROSE，EUS-FNA / 2024SDU-QILU-1
- Conditions
- The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Taian City Central Hospital, Qilu Hospital of Shandong University (Qingdao), Shandong Provincial Hospital, Liaocheng People's Hospital, The Affiliated Hospital of Qingdao University, Binzhou People's Hospital, Binzhou Medical University, 960th Hospital of PLA, Weifang Yidu Central Hospital
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 5 Dec 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.
This is an observational study with a prospective, multicenter, disgnostic design. An artificial intelligence system named ROSE-AI system was developed using cytopathological slide images taken by microscope camera or smartphone of pancreas, bile duct, liver and lymph node, collected retrospectively from patients who underwent EUS-FNA and ROSE, and the performance of ROSE-AI system was validated in the datasets collected prospectively.This study aims to assist endoscopists in conducting rapid on-site cytopathology evaluations during EUS-FNA without the presence of cytopathologists. In addition, the diagnostic field was compared between the cytopathologists and ROSE-AI system, endoscopists with or without ROSE-AI system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing EUS-FNA and ROSE | – | Diagnostic Test: ROSE-AI systemPatients ≥18 years with pancreatic, bile duct, hepatic, or lymph node lesions accepted EUS-FNA and ROSE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with pancreatic, bile duct, hepatic, or lymph node lesions undergoing EUS-FNA and ROSE from the participating hospitals.
Key inclusion criteria (2 listed)
- the patient age ≥18 years accepted EUS-FNA+ROSE.
- agree to participate in the research and be able to sign written informed consent.
Key exclusion criteria (7 listed)
- uncorrectable coagulopathy (PTT >50 seconds or INR >1.5) and/or uncorrectable thrombocytopenia (platelet count <50 × 109 /L).
- patients who were too clinically ill to undergo an EUS examination.
- lesions that were deemed inaccessible for EUS-guided sampling.
- unsuccessful EUS-FNA (e.g., failure to obtain an adequate specimen, patient intolerance, intraoperative accidents, etc.).
- Patients with unqualified ROSE smear.
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 systemThe cytopathological slide images of the patients' ROSE samples will be identified by the ROSE-AI system. | Diagnostic test | Patients undergoing EUS-FNA and ROSE |
Primary outcome
the accuracy, sensitivity and specificity of the ROSE-AI system in identifying malignant/non-malignant ROSE samples
Time frame: During procedure
The primary outcome of the study is to evaluate the performance of the ROSE-AI system in identifying the malignant/non-malignant ROSE samples of pancreatic, bile duct, hepatic and lymph node based on both images taken by microscope camera and smartphone, and comparing the performance between the ROSE-AI system and endoscopists, cytopathologists.
1 secondary outcome
comparing the diagnostic performance between endoscopists with ROSE-AI system and without ROSE-AI system
Time frame: During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node, run by Qilu Hospital of Shandong University at 1 site 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen Li (18560086106, qilulizhen@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the accuracy, sensitivity and specificity of the ROSE-AI system in identifying malignant/non-malignant ROSE samples (time frame: During procedure). 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 5 Dec 2024.