PancancerNCT07269236
Prospective Real-World Study of Multimodal AI
An observational study of Pancancer, run by Nanfang Hospital, Southern Medical University at 2 sites in China.
Trial summary
This project proposes to collect prospective multimodal data-such as pathology, imaging, and clinical information-and to perform integrative analyses. AI technologies can offer novel solutions for disease classification, tumor grading, histological subtyping, molecular subtyping, selection of chemotherapy regimens… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancancer
- How many people
- 2,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2025to Sep 2030
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion criteria comprised patients with definitive pathological diagnoses. All cases were prospectively collected from Nanfang Hospital, Southern Medical University (NFHSMU) .
Who may be able to join
- Age 18 years or older.
- Patients with available digitized pathology slides, radiological imaging, and corresponding clinical data.
Who cannot join
- 1.Patients with missing data or specimens not meeting quality control requirements for analysis.
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
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Zhongshan City People's Hospital
Zhongshan, Guangdong, 513000
About this study
Official title: Prospective Real-World Study of a Multimodal Artificial Intelligence Model Across Disease Types
This project proposes to collect prospective multimodal data-such as pathology, imaging, and clinical information-and to perform integrative analyses. AI technologies can offer novel solutions for disease classification, tumor grading, histological subtyping, molecular subtyping, selection of chemotherapy regimens, risk stratification, treatment response prediction, report generation, and intelligent question-answering. This research provides important support for precision medicine and individualized treatment and has significant theoretical and practical implications. Conducting a prospective randomized controlled study better aligns with clinical application requirements and can accelerate the comprehensive deployment of AI systems.
- Conditions
- Pancancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ZSCPH validation dataset | Approximately 1,000 prospective patients across various disease types will have digitized scanned images, imaging information, and clinicopathological data provided, collected from Zhongshan People's Hospital (Zhongshan, Guangdong, China) between October 2025 and September 2030. | |
| NFHSMU validation dataset | We conducted a prospective validation study to compare the diagnostic performance among pathologists, our multimodal artificial intelligence model . This study was initiated on October 1, 2025 at Nanfang Hospital, Southern Medical University (NFHSMU). | |
| Randomized controlled trial | We conducted a prospective randomized controlled trial to compare the diagnostic performance among pathologists, the multimodal artificial intelligence model, and pathologist-with-model-assisted diagnosis at Nanfang Hospital of Southern Medical University (NFHSMU).The trial commenced data collection on October 1, 2025 to establish the NFHSMU randomized controlled trial dataset. Following quality control, the slides were randomly allocated (1:1:1 ratio) into three groups:Model-only group/Pathologist-only group/Model-assisted pathologist group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under ROC curve (AUC)
Area under the curve
Measured: Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained
Secondary outcomes (2)
Specificity
The true negative rate (TNR) of the diagnostic platform, which is the ratio between the number of negative individuals correctly categorized by platform and the total number of actual negative individuals (%).
Measured: Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained
Sensitivity
The true positive rate (TPR) of the diagnostic platform, which is the ratio between the number of positive individuals correctly categorized by platform and the total number of actual positive individuals (%).
Measured: Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Oct 2025
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancancerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Liang, Study director, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269236
- Sponsor's protocol ID
- NFEC-2025-602
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Individual data sharing
- No: Requests for the data collected and analyzed in this study will be considered if the application is in line with public benefits and the applicant is willing to sign a data access agreement. Contact can be through the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Real-World Study of a Multimodal Artificial Intelligence Model Across Disease Types
- ClinicalTrials.gov ID
- NCT07269236
- Acronym / sponsor ID
- NFEC-2025-602
- Conditions
- Pancancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 8 Dec 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.
This project proposes to collect prospective multimodal data-such as pathology, imaging, and clinical information-and to perform integrative analyses. AI technologies can offer novel solutions for disease classification, tumor grading, histological subtyping, molecular subtyping, selection of chemotherapy regimens, risk stratification, treatment response prediction, report generation, and intelligent question-answering. This research provides important support for precision medicine and individualized treatment and has significant theoretical and practical implications. Conducting a prospective randomized controlled study better aligns with clinical application requirements and can accelerate the comprehensive deployment of AI systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZSCPH validation dataset | – | –Approximately 1,000 prospective patients across various disease types will have digitized scanned images, imaging information, and clinicopathological data provided, collected from Zhongshan People's Hospital (Zhongshan, Guangdong, China) between October 2025 and September 2030. |
| NFHSMU validation dataset | – | –We conducted a prospective validation study to compare the diagnostic performance among pathologists, our multimodal artificial intelligence model . This study was initiated on October 1, 2025 at Nanfang Hospital, Southern Medical University (NFHSMU). |
| Randomized controlled trial | – | –We conducted a prospective randomized controlled trial to compare the diagnostic performance among pathologists, the multimodal artificial intelligence model, and pathologist-with-model-assisted diagnosis at Nanfang Hospital of Southern Medical University (NFHSMU).The trial commenced data collection on October 1, 2025 to establish the NFHSMU randomized controlled trial dataset. Following quality control, the slides were randomly allocated (1:1:1 ratio) into three groups:Model-only group/Pathologist-only group/Model-assisted pathologist group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion criteria comprised patients with definitive pathological diagnoses. All cases were prospectively collected from Nanfang Hospital, Southern Medical University (NFHSMU) .
Key inclusion criteria (2 listed)
- Age 18 years or older.
- Patients with available digitized pathology slides, radiological imaging, and corresponding clinical data.
Key exclusion criteria (1 listed)
- 1.Patients with missing data or specimens not meeting quality control requirements for analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under ROC curve (AUC)
Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained
Area under the curve
2 secondary outcomes
Specificity
Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained
Sensitivity
Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained
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 8 Dec 2025.
- Individual participant dataSharing planned: No. Requests for the data collected and analyzed in this study will be considered if the application is in line with public benefits and the applicant is willing to sign a data access agreement. Contact can be through the corresponding author.
Related trials for Pancancer
RecruitingObservational study
Prospective Pathology Foundation Models
Pancancer
Enrolling by invitationObservational study
Retrospective Pathology Foundation Models
Pancancer
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.
Li Liang study director
Nanfang Hospital, Southern Medical University
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 Pancancer, run by Nanfang Hospital, Southern Medical 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 2 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: enrolling by invitation, as of the sponsor's last update on 8 Dec 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under ROC curve (AUC) (time frame: Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained). 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 8 Dec 2025.