Actively Recruiting
Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma
Led by University of California, San Francisco · Updated on 2025-03-30
289
Participants Needed
2
Research Sites
189 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older at screening visit
- Patients currently receiving clinical care at Muhimbili National Hospital-Upanga or MNH-Mloganzila
- ESCC cases: confirmed diagnosis by histology or planned endoscopy with biopsy for suspected ESCC based on clinical criteria
- Non-ESCC participants: scheduled for endoscopy for non-malignant conditions without esophageal cancer symptoms
- Ability to swallow liquid (Ogilvie's score less than 3)
- Well enough to participate in a 20-minute interview or have a close relative to do so
- Willingness to be contacted in person or by phone 7-10 days after EsophaCap sponge administration
- Native of Tanzania
- Written informed consent (and assent if applicable) obtained with ability to comply with study requirements
You will not qualify if you...
- Known pregnancy during study participation
- Any condition or abnormality compromising patient safety or data quality as judged by investigator
- Clinical instability such as low blood pressure or recent cardiovascular event
- History of upper gastrointestinal bleeding or peptic ulcer disease within past 3 months
- Known esophageal varices
- Use of anticoagulation or antiplatelet medications for high-risk conditions
- Active extra-esophageal malignancy not in remission
- History of non-malignant esophageal strictures or esophageal stents
- History of radiation therapy to head, neck, gastrointestinal tract, or thorax
- Chemotherapy received within last 12 months
- Major surgery for esophageal cancer
- Symptoms or history concerning tracheoesophageal fistula
- Known small bowel obstruction
- History of bleeding complications during esophageal biopsy
- History of head and neck malignancy
- Known bleeding disorder or thrombocytopenia (platelets less than 50,000 per microliter)
- Not a permanent resident or native of Tanzania
- Inability to follow instructions or provide informed consent
- Allergy to iodine (non-ESCC group)
- Presence of goiter (non-ESCC group)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Muhimbili National Hospital (MNH)
Dar es Salaam, Mloganzila, Tanzania
Actively Recruiting
2
Muhimbili National Hospital (MNH)
Dar es Salaam, Upganda, Tanzania
Actively Recruiting
Research Team
G
Geoffrey Buckle, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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