Performance of the ModelNCT06567028
OSPM-Enhanced AI Model to Identify Premalignant and Malignant Ocular Surface Tumors
An observational study of Performance of the Model, run by Ningbo Eye Hospital at 1 site in China.
Trial summary
An OSPM-enhanced deep learning model has been developed for identifying premalignant and malignant tumors using data retrospectively collected from the Ningbo Eye Hospital, Jiangdong Eye Hospital, and the Eye Hospital of Wenzhou Medical University. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Performance of the Model
- What is being tested?
- OSPM-Enhanced AI Model
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Nov 2024
- 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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Child, Adult, Older Adult
Who may be able to join
- ● Ocular surface tumor images with histopathological findings
Who cannot join
- ● Low-quality images
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of an OSPM-Enhanced Deep Learning Model for Identifying Premalignant and Malignant Ocular Surface Tumors
An OSPM-enhanced deep learning model has been developed for identifying premalignant and malignant tumors using data retrospectively collected from the Ningbo Eye Hospital, Jiangdong Eye Hospital, and the Eye Hospital of Wenzhou Medical University. To further substantiate the model's effectiveness, we intend to evaluate it prospectively at Ningbo Eye Hospital.
- Conditions
- Performance of the Model
- Being tested
- OSPM-Enhanced AI Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSPM-Enhanced AI ModelDiagnostic test
Analyze tumor images using the model developed in our study
What is being measured
The primary outcome is the main question the study is designed to answer.
AUROC
area under the receiver operating characteristic curve
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Jun 2024
- Primary completion1 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance of the ModelStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567028
- Sponsor's protocol ID
- NEH202408
- Status last verified
- Mar 2025
- First submitted
- 20 Aug 2024
- Last updated
- 26 Mar 2025
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of an OSPM-Enhanced Deep Learning Model for Identifying Premalignant and Malignant Ocular Surface Tumors
- ClinicalTrials.gov ID
- NCT06567028
- Acronym / sponsor ID
- NEH202408
- Conditions
- Performance of the Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ningbo Eye HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 22 Aug 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.
An OSPM-enhanced deep learning model has been developed for identifying premalignant and malignant tumors using data retrospectively collected from the Ningbo Eye Hospital, Jiangdong Eye Hospital, and the Eye Hospital of Wenzhou Medical University. To further substantiate the model's effectiveness, we intend to evaluate it prospectively at Ningbo Eye Hospital.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Child, Adult, Older Adult
Key inclusion criteria (1 listed)
- ● Ocular surface tumor images with histopathological findings
Key exclusion criteria (1 listed)
- ● Low-quality images
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 |
|---|---|---|
| OSPM-Enhanced AI ModelAnalyze tumor images using the model developed in our study | Diagnostic test | – |
Primary outcome
AUROC
Time frame: 3 months
area under the receiver operating characteristic curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Performance of the Model, run by Ningbo Eye Hospital 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 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: finished, as of the sponsor's last update on 26 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUROC (time frame: 3 months). 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 26 Mar 2025.