RECRUITING

Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effectiveness and Performance of a Mobile, Automated, Optical Biopsy Technology for Esophageal Cancer Screening: A Clinical Study in Brazil and the United States

Quick Facts

Study Start:2025-02-17
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06435286

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment, including patients with a known history of head/neck squamous cell cancer; heavy smoking and alcohol, other dietary or geographic risk factors or prior dysplasia
  2. * Patients \>18 years old.
  3. * Patients of any sex or gender.
  4. * Patients who are willing and able to give informed consent.
  1. * Allergy or prior reaction to the fluorescent contrast agent proflavine hemisulfate.
  2. * Patients who are unable to give informed consent.
  3. * Known advanced squamous cell carcinoma of the distal esophagus or dysplastic/suspected malignant esophageal lesion greater than or equal to 2 cm in size not amenable to endoscopic therapy.
  4. * Patient unable to undergo routine endoscopy with biopsy:
  5. * Women who are pregnant or breast feeding,
  6. * Prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0,
  7. * Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues.

Contacts and Locations

Study Contact

Sharmila Anandasabapathy, MD
CONTACT
7137980950
sharmila.anandasabapathy@bcm.edu
Adrianna O Maliga, MPH
CONTACT
(713) 798-5987
adrianna.maliga@bcm.edu

Principal Investigator

Sharmila Anandasabapathy, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Baylor St. Luke's Medical Center
Houston, Texas, 77030
United States
Ben Taub Hospital (Harris Health Systems)
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Sharmila Anandasabapathy, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-17
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2025-02-17
Study Completion Date2027-03-01

Terms related to this study

Keywords Provided by Researchers

  • Squamous cell neoplasia
  • Proflavine
  • Lugol's chromoendoscopy

Additional Relevant MeSH Terms

  • Suspected or Known Squamous Cell Neoplasia
  • Prior History of Squamous Cell Dysplasia and /or Neoplasia