New method for early detection of esophageal cancer

Investigation of a Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma

This study is testing a new swallowable sponge device to see if it can help find esophageal cancer and its early signs in people at high risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 289 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Dar es Salaam, Mloganzila and 1 other locations)
• Trial ID: NCT05028725 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel approach using a swallowable sponge device called 'EsophaCap' combined with a molecular biomarker assay to detect esophageal squamous cell carcinoma (ESCC) and its precursor, esophageal squamous dysplasia (ESD). Participants will undergo esophageal sponge sampling, and the samples will be analyzed for specific methylation markers associated with ESCC. The study aims to determine the sensitivity and specificity of this diagnostic strategy among patients with confirmed ESCC and ESD. If successful, this method could significantly improve early detection and screening for esophageal cancer in high-incidence regions like Tanzania.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed or suspected esophageal squamous cell carcinoma or dysplasia.

Not a fit: Patients with alternative diagnoses that do not involve esophageal squamous cell carcinoma or dysplasia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection of esophageal cancer, improving patient outcomes and survival rates.

How similar studies have performed: Other studies have shown promise in using biomarker detection for cancer screening, but this specific approach is novel.

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

Where this trial is running

Dar es Salaam, Mloganzila and 1 other locations

• Muhimbili National Hospital (MNH) — Dar es Salaam, Mloganzila, Tanzania (Recruiting)
• Muhimbili National Hospital (MNH) — Dar es Salaam, Upganda, Tanzania (Recruiting)

Study contacts

• Principal investigator: Geoffrey Buckle, MD, MPH — University of California, San Francisco
• Study coordinator: Geoffrey Buckle, MD, MPH

Conditions Esophageal Squamous Cell Carcinoma; Esophageal Squamous Dysplasia; EsophaCap; Biomarker Detection; Cancer Detection; Chromoendoscopic screening