Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma

Prior treatment

• Patients who have previously received chemotherapy in the last 12 months
• Patients with an active extra-esophageal malignancy (not currently in remission) or any history of a non-cutaneous malignancy diagnosed within the previous five years.

Other illness

• 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.
• Any history of upper gastrointestinal bleeding within the past 3 months (including reported history of hematemesis and/or melena).
• Diagnosis of peptic ulcer disease within the last 3 months.
• Known history of esophageal varices.
• Patients taking anticoagulation or antiplatelet therapy/medication (warfarin, clopidogrel, aspirin, heparin or enoxaparin) for high-risk conditions.
• Patients with an active extra-esophageal malignancy (not currently in remission).
• Patient with a known history of a non-malignant esophageal stricture.
• Patients with a history of radiation therapy to the head, neck, any part of the gastrointestinal tract (including esophagus) or thorax.
• Patients with any history of major surgery for esophageal cancer (e.g. esophageal bypass, esophagectomy, etc.).
• Patients who have a known history of or clinical symptoms concerning for tracheoesophageal fistula (aspiration history, severe cough)
• Patients with a known history of small bowel obstruction
• Patients with a history of bleeding complications during esophageal biopsy.
• Patients with any history of a head and neck malignancy.
• Patients with a known bleeding disorder
• 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.
• Any history of upper gastrointestinal bleeding within the past 3 months (including reported history of hematemesis and/or melena).
• Diagnosis of peptic ulcer disease within the last 3 months.
• Known history of esophageal varices.
• Patients taking anticoagulation or antiplatelet therapy/medication (warfarin, clopidogrel, aspirin, heparin or enoxaparin) for high-risk conditions.
• Patient with a known history of esophageal strictures disabling passage of the capsule.
• Patients with a history of radiation therapy to the head, neck, any part of the gastrointestinal tract (including esophagus) or thorax.
• Patients with a known history of small bowel obstruction
• Patients with a known bleeding disorder
• Allergy to iodine

Lab values

• Patients with known thrombocytopenia (less than 50,000 platelets per microliter)
• Patients with known thrombocytopenia (less than 50,000 platelets per microliter)

Other

• ESCC Cases (Group 1):
• Known pregnancy during participation in the study.
• Clinical instability (i.e. hypotension or a recent cardiovascular event).
• Patients with esophageal stents currently in place.
• Individuals who are not permanent residents or natives of Tanzania.
• Inability to follow instructions.
• Unable to provide informed consent.
  • Non-ESCC study participants (Group 2):
• Known pregnancy during participation in the study.
• Clinical instability (i.e. hypotension or a recent cardiovascular event).
• Patient with esophageal stents currently in place.
• Individuals who are not permanent residents or natives of Tanzania.
• Presence of goiter.
• Inability to follow instructions.
• Unable to provide informed consent

• 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.