Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Aug 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new method to help detect esophageal squamous cell carcinoma (ESCC), a type of throat cancer, and a related condition called esophageal squamous dysplasia (ESD). The researchers are using a special device called the 'EsophaCap,' which is a swallowable sponge that collects samples from the esophagus. These samples are then tested for specific genetic markers that can indicate the presence of cancer or the risk of developing it in the future. This early detection method could significantly improve cancer control efforts, especially in areas like Tanzania where ESCC is common.

To participate in this study, you need to be at least 18 years old and currently receiving care at specific hospitals in Tanzania. If you have a confirmed diagnosis of ESCC or are undergoing tests for suspected ESCC, you may be eligible. Participants will take part in a brief interview and will be contacted about a week after using the 'EsophaCap' device to discuss their experience. It’s important to know that there are certain health conditions that may exclude you from participating, such as pregnancy or recent gastrointestinal bleeding. If you’re interested, you’ll need to give your written consent to join the study.

Gender

ALL

Eligibility criteria

• 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 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.
• 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 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).
• • 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 the gastrointestinal 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. 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
• • 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 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).
• • 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) or any history of a non-cutaneous malignancy diagnosed within the previous five years.
• • Patient with a known history of esophageal strictures disabling passage of the capsule.
• • Patient with esophageal stents currently in place.
• • 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
• • 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