Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
In the current protocol, we propose a study to evaluate a novel, combined esophageal sponge-methylation biomarker strategy for the early detection of esophageal squamous cell carcinoma (ESCC) as well as its precursor, esophageal squamous dysplasia (ESD). This strategy leverages the 'EsophaCap', a swallowable, retrievable sponge, with subsequent evaluation of the sample using a novel molecular biomarker assay. This biomarker assay evaluates methylation levels in select genes, which have been shown to differ significantly between ESCC cases and controls in pilot studies. Detection of methylation markers highly associated with ESCC could help identify patients with concurrent ESCC or at high risk of imminently developing this condition. If successful, this strategy could result in a paradigm shift for esophageal cancer control strategies in Tanzania and other high-incidence ESCC regions.
Eligibility criteria
Qualifiers
Male or female >= 18 years of age at screening visit.
Patients are currently seen for clinical care at Muhimbili National Hospital (MNH)-Upanga or at MNH-Mloganzila.
Patient meets one of the following two criteria-
Patients with a confirmed diagnosis of ESCC as evidenced by histological confirmation OR
Disqualifiers
Known pregnancy during participation in the study.
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Clinical instability (i.e. hypotension or a recent cardiovascular event).
Any history of upper gastrointestinal bleeding within the past 3 months (including reported history of hematemesis and/or melena).
Trial design
Treatments tested in this trial
- EsophaCap Sponge
- Chromoendoscopy
- EsoCAN assay
Treatment groups
289 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of California, San Francisco
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Johns Hopkins University
Collaborator
Muhimbili University of Health and Allied Sciences
Collaborator
CapNostics, LLC
Collaborator
Source ClinicalTrials.gov