Condition: Suspected or Known Squamous Cell Neoplasia · Prior History of Squamous Cell Dysplasia and /or Neoplasia · Sponsor: Baylor College of Medicine
In a previous clinical trial in China and the United States (US), the investigators developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of esophageal squamous cell neoplasia (ESCN). The trial revealed higher specificity for qualitative (visual) interpretation by experts but not the novice and in the surveillance arm (100% vs. 19%, p \<0.05). In the screening arm, diagnostic yield (neoplastic biopsies/total biopsies) increased 3.6 times (8 to 29%); 16% of patients were correctly spared any biopsy, and 18% had a change in clinical plan. In a pilot study in Brazil, the investigators tested a software-assisted mHRME with deep-learning software algorithms to aid in the detection of neoplastic images and determine the performance, efficiency, and impact of the AI-mHRME when to Lugol's chromoendoscopy (LCE) alone and when using AI-mHRME with LCE. In this clinical trial, the investigators will build on the Brazil pilot trial data to optimize an artificial intelligence (AI) mHRME and evaluate its clinical impact and implementation potential in ethnically and socioeconomically diverse populations in the US and Brazil.
This description comes directly from the study's public registry record.
Mimi C Tan, MD, MPH · 7137980950 · mc2@bcm.edu
Adrianna O Maliga, MPH · (713) 798-5987 · adrianna.maliga@bcm.edu
Always discuss trial participation with your own doctor first.
| Baylor St. Luke's Medical Center | Houston, Texas, United States | Recruiting |
| Ben Taub Hospital (Harris Health Systems) | Houston, Texas, United States | Recruiting |
| Hospital de Cancer de Barretos - Fundacao Pio XII | Barretos, São Paulo, Brazil | Recruiting |
| Instituto do Câncer do Estado de São Paulo | São Paulo, São Paulo, Brazil | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06435286