Status:
COMPLETED
Cytosponge™ Feasibility Study in Tanzania
Lead Sponsor:
International Agency for Research on Cancer
Collaborating Sponsors:
Kilimanjaro Clinical Research Institute
University of Cambridge
Conditions:
Esophageal Diseases
Esophagus SCC
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
A Tanzanian pilot study to test the feasibility of using the Cytosponge™ device - a less-invasive endoscopy alternative - for research on esophageal squamous cell carcinoma in African settings.
Detailed Description
The Cytosponge™ consists of a spherical mesh enclosed in a gelatine capsule and attached to a string. The capsule is swallowed with the use of water and allowed to reach the stomach while remaining at...
Eligibility Criteria
Inclusion
- 30 years or older.
- Resident of Kilimanjaro Region for 10 years or more.
Exclusion
- Eaten or drank within the last 4 hours.
- Known current pregnancy.
- Objection to CytoSCCAPE data collection.
- Symptoms of dysphagia (difficulty swallowing).
- Recorded history of oropharyngeal, esophageal or gastric cancer
- Received prior surgical intervention to the esophagus.
- Esophageal varices, stricture or requiring esophageal dilation.
- Recorded cirrhosis of the liver.
- Swallowing difficulty due to cerebrovascular accident or neurological disorder.
- Recent history of vomiting blood.
- Recent use of anticoagulation therapy/medication.
- Myocardial infarction or any cardiac event within the last 6 months.
- Lacking capacity to provide informed consent.
- Unwilling to swallow beef gelatine capsule due to dietary preferences.
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04090554
Start Date
September 24 2019
End Date
December 30 2020
Last Update
August 25 2021
Active Locations (1)
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1
Majengo Unit, Kilimanjaro Clinical Research Institute
Moshi, Tanzania