Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma

Inclusion Criteria:

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 histologicalconfirmation OR

• Patient planned to undergo EGD with biopsy for suspected ESCC based upon any one ofthe 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 forthese 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 closerelative who is able to do so on their behalf.

• Patients must be willing to be contacted either in person or via phone 7-10 daysfollowing administration of the 'EsophaCap' sponge device.

• Native of Tanzania.

• Written informed consent (and assent when applicable) obtained from subject orsubject's legal representative and ability for subject to comply with therequirements 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 nosymptoms 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 closerelative who is able to do so on their behalf.

• Patients must be willing to be contacted either in person or via phone 7-10 daysfollowing administration of the 'EsophaCap' sponge device.

• Native of Tanzania.

• Written informed consent (and assent when applicable) obtained from participant orparticipant's legal representative and ability for subject to comply with therequirements of the study.

Exclusion Criteria:

ESCC Cases (Group 1):

• Known pregnancy during participation in the study.

• Presence of a condition or abnormality that in the opinion of the Investigator wouldcompromise 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 (includingreported 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 esophageal stents currently in place.

• Patients with a history of radiation therapy to the head, neck, any part of thegastrointestinal tract (including esophagus) or thorax.

• Patients who have previously received chemotherapy in the last 12 months

• Patients with any history of major surgery for esophageal cancer (e.g. esophagealbypass, esophagectomy, etc.).

• Patients who have a known history of or clinical symptoms concerning fortracheoesophageal 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

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

• 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.

• Presence of a condition or abnormality that in the opinion of the Investigator wouldcompromise 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 (includingreported 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) orany history of a non-cutaneous malignancy diagnosed within the previous five years.

• Patient with a known history of esophageal strictures disabling passage of thecapsule.

• Patient with esophageal stents currently in place.

• Patients with a history of radiation therapy to the head, neck, any part of thegastrointestinal tract (including esophagus) or thorax.

• Patients with a known history of small bowel obstruction

• Patients with a known bleeding disorder

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

• Individuals who are not permanent residents or natives of Tanzania.

• Allergy to iodine

• Presence of goiter.

• Inability to follow instructions.

• Unable to provide informed consent