An observational study in Jaundice, Deep Learning and Hyperbilirubinemia, sponsored by Air Force Military Medical University, China. Recruiting at 1 site in China. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by Air Force Military Medical University, China · Observational
The primary efficacy endpoints are the standard deviation and coefficient of determination (R2) between predicted and actual values for the bilirubin regression model, and the grading accuracy for the jaundice severity classification model. The secondary efficacy endpoint is the mean percentage error between predicted and actual bilirubin values. There are no relevant safety risks.
Statistical differences for categorical variables (e.g., jaundice grading evaluation indicators) will be analyzed using the chi-square test or Fisher's exact probability test. For continuous variables (e.g., bilirubin prediction evaluation indicators), t-tests (normal distribution) or non-parametric tests (non-normal distribution) will be used. The 95% confidence interval for jaundice grading accuracy will be calculated using the Wilson method.
The study duration is estimated to be 3 months.
84 studies on the registry are indexed under Jaundice; 13 are open to participants now.
This study's planned enrollment of 270 is above the median of 200 across 31 observational studies indexed under Jaundice.
Browse Jaundice studies →Air Force Military Medical University, China is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study Population Description:
The study will include a total of 270 patients, both male and female, aged 14 years and above. The participants should not have any pre-existing conditions that may affect the color of their sclera. They should be able to follow instructions and complete the scleral imaging procedure. The patient population will primarily consist of individuals undergoing treatment for colorectal polyps, pancreatitis, pancreatic tumors, hepatobiliary stones, or biliary tract tumors.
Screening Procedure:
Potential participants will be screened using oral queries to assess their eligibility based on the inclusion and exclusion criteria. A brief ocular examination will be performed to rule out any apparent ocular surface disorders. Eligible participants will be provided with a detailed explanation of the study objectives, procedures, and potential risks and benefits. Written informed consent will be obtained from all participants prior to enrollment in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age 14 years or older. Subjects who are visiting the Gastroenterology Department of Xijing Hospital and will undergo liver function tests on the same day. The disease spectrum of the subjects mainly includes pancreatitis, pancreatic tumors, hepatobiliary stones, biliary tumors, and colonic polyps.
Exclusion Criteria:
Subjects with diseases that may cause abnormal changes in scleral color, such as glaucoma, Wilson's disease, pterygium, or scleritis.
Subjects who have recently consumed a large amount of carotenoid-rich foods (such as oranges or carrots).
Subjects who are unable to provide .
Elimination Criteria:
Subjects with incomplete scleral exposure due to limited eye movement or excessive tension during external eye examination.
Subjects who are unable to understand the instructions for eye rotation during scleral examination or are unable to cooperate due to reasons such as poor hearing.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The cohort consists of at least 270 subjects consecutively enrolled from the Department of Gastroenterology at Xijing Hospital. The subjects will be followed prospectively over a period of time to collect data on their age, medical information, scleral images, and liver function test results. The cohort includes patients with various liver diseases and varying degrees of jaundice severity.
Loss of predicted bilirubin levels
Standard deviation and mean average percentage error between predicted and actual bilirubin levels for the bilirubin regression model.
Time frame: Immediately after test completion
Classification accuracy
Classification accuracy for the jaundice severity grading model
Time frame: Immediately after test completion
Plan to share: No
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Air Force Military Medical University, China →