Other Clinical Trial - Artificial Intelligence Patient App for RDEB SCCs

Status Active, not recruiting

Clinical Trial Summary

In this study, an artificial intelligence model to detect squamous cell carcinomas (SCC) on photos of recessive dystrophic epidermolysis bullosa (RDEB) skin is developed. The ultimate goal is to integrate this model into an app for patients and physicians, to help detect SCCs in RDEB early. SCCs which rapidly metastasize are the main cause of death in adults with RDEB. The earlier an SCC is recognized, the easier it can be removed and the better the outcome. AI leverages computer science to perform tasks that typically require human intelligence and has recently been used to identify skin cancers based on images. We are currently developing an AI approach for early detection of SCC and distinction of malignancy from chronic wounds and other RDEB skin findings. The aim is to create a web application for patients with RDEB to upload images of their skin and get an output as to SCC present/ no SCC. This will be especially valuable for patients with difficult access to medical expertise and those who are hesitant to allow full skin examination at each visit, often because of fear of biopsies. Thus, this project will directly benefit patients by allowing early recognition of SCCs and will empower patients and their families by providing a home use tool. So far, the study team has mainly used professional images (photographs taken in hospital settings by physicians, nurses, and clinical photographers) of both SCCs in RDEB and images of RDEB skin without SCC to develop and train the AI model. The images that are expected in a real-life setting will mostly be pictures taken by patients or family members with their phones or digital cameras. These images have different properties regarding resolution, focus, lighting, and backgrounds. Incorporating such images will be crucial in the upcoming phases of model development-testing and validation-for the web application be a success for patients.

Clinical Trial Description

This project will enroll adolescents and adults with RDEB and history of at least one SCC. The survey and consents will be provided in English, Spanish, German, French, Arabic, Chinese, and Russian. The study team is inviting people with RDEB around the world to participate and are hoping that approximately 100 people will provide images. Participants will be asked to complete the survey and upload photographs of SCC(s) using the links below. Depending on the number of SCCs they have had and the number of photos they want to provide, the survey will take approximately 15-20 minutes to complete. To participate in this study, please follow this link: https://redcap.nubic.northwestern.edu/redcap/surveys/?s=JH9LHR4CC4R4H3HN ;

Study Design

Related Conditions & MeSH terms

Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica

Clinical Trial Details

NCT number	NCT05843994
Study type	Observational
Source	Northwestern University
Contact
Status	Active, not recruiting
Phase
Start date	February 13, 2023
Completion date	June 30, 2024

View Details

See also
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Completed	`NCT04908215` - INM-755 (Cannabinol) Cream for Treatment of Epidermolysis Bullosa	Phase 2
Terminated	`NCT00587223` - Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)	Phase 3
Active, not recruiting	`NCT04171661` - Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa	Early Phase 1
Terminated	`NCT00533572` - Recessive Dystrophic Epidermolysis Bullosa Screening for Possible Gene Transfer	N/A
Completed	`NCT00904163` - Characteristics of Adult Patients With Recessive Dystrophic Epidermolysis Bullosa	N/A
Recruiting	`NCT03786237` - Rigosertib for RDEB-SCC	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.