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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
EsophaCap Sponge
DeviceNon-invasive strategy to sample esophageal tissue
Chromoendoscopy
Procedure/SurgeryLugol's iodine chromoendoscopy is a technique that is used to identify mucosal abnormalities of the esophagus
EsoCAN assay
DeviceBiomarker Test
Treatment groups
289 Participants
are divided into 3 treatment groupsGroup A: Esophageal Squamous Cell Carcinoma (ESCC) CasesExperimental treatment 2 interventions
Group B: Non-ESCC, Esophageal squamous dysplasia (ESD) CasesExperimental treatment 3 interventions
Group C: Non-ESCC, Control GroupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Proportion of True-Positives (sensitivity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESCC cases & controls only)
The proportion of participants with a positive EsoCAN assay result, among patients with histologically-confirmed Esophageal Squamous Cell Carcinoma (ESCC). The following equation will be used as a cut point for ESCC using the EsoCAN assay \[0.139\*log2(gene A)\] + \[0.176\* log2(gene B)\] + \[0.185\* log2(gene C)\], whereas a cutoff value (for the numerical index produced by this formula) of greater than -2.327 is classified as positive.
Time frame
Up to 38 days2
Proportion of True-Negatives (specificity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESCC cases & controls only)
The proportion of participants with a negative EsoCAN assay result for will be reported, among study participants who are classified as controls. The following equation will be used as a cut point for ESCC using the EsoCAN assay \[0.139\*log2(gene A)\] + \[0.176\* log2(gene B)\] + \[0.185\* log2(gene C)\], whereas a cutoff value (for the numerical index produced by this formula) of less than -2.327 is classified as negative.
Time frame
Up to 38 daysSecondary outcomes
1
Proportion of True-Positives (sensitivity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESD cases & controls only)
The proportion of participants with both a positive EsoCAN assay result, among patients with histologically-confirmed Esophageal Squamous Dysplasia (ESD). The following equation will be used as a cut point for ESD: \[0.139\*log2(gene A)\] + \[0.176\* log2(gene B)\] + \[0.185\* log2(gene C)\], whereas a cutoff value (for the numerical index produced by this formula) of greater than -2.327 is classified as positive.
Time frame
Up to 38 days2
Proportion of True-Negatives (specificity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESD cases & controls only)
The proportion of participants with a negative EsoCAN assay result will be reported. The following equation will be used as a cut point for ESD: \[0.139\*log2(gene A)\] + \[0.176\* log2(gene B)\] + \[0.185\* log2(gene C)\], whereas a cutoff value (for the numerical index produced by this formula) of less than -2.327 is classified as negative.
Time frame
Up to 38 days3
Proportion of study participants who successfully swallow the esophageal sponge device
The success of swallowing the esophageal sponge device will be determined by the clinical team overseeing the EsophaCap' administration and categorized as a dichotomous response of Yes (successful) or No (not successful).
Time frame
Up to 38 days4
Proportion of study participants who experienced an esophageal sponge device-related adverse event in the lead in cohort of ESCC Cases
Adverse events for the lead in cohort with histologically confirmed or suspected ESCC based upon pre-specified clinical criteria will be reported and graded and classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame
Up to 38 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
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