Investigation of a Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma
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.
⁃ ESCC Cases (Group 1):
• 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
• Patient planned to undergo EGD with biopsy for suspected ESCC based upon any one of the following clinical criteria: (1) findings on computed tomography (CT) scan; (2) findings on barium swallow; (3) findings on endoscopy without biopsy confirmation, (4) symptoms of dysphagia and/or odynophagia without an alternative explanation for these symptoms.
• Patient must be able to swallow liquid (Ogilvie's score \< 3).
• Patients must be well enough to participate in a 20-minute interview or have a close relative who is able to do so on their behalf.
• Patients must be willing to be contacted either in person or via phone 7-10 days following administration of the 'EsophaCap' sponge device.
• Native of Tanzania.
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
⁃ Non-ESCC study participants (Group 2):
• Male or female ≥ 18 years of age at screening visit.
• Patients are currently seen for clinical care at MNH-Upanga or at MNH-Mloganzila.
• Patient is scheduled to undergo EGD for a suspected non-malignant condition with no symptoms concerning for esophageal cancer (i.e. dysphagia or odynophagia).
• Patient must be able to swallow liquid (Ogilvie's score \< 3).
• Patients must be well enough to participate in a 20-minute interview or have a close relative who is able to do so on their behalf.
• Patients must be willing to be contacted either in person or via phone 7-10 days following administration of the 'EsophaCap' sponge device.
• Native of Tanzania.
• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability for subject to comply with the requirements of the study.