Cytospongeâ„¢ Feasibility Study in Tanzania (NCT04090554) | Clinical Trial Compass
CompletedNot Applicable
Cytospongeâ„¢ Feasibility Study in Tanzania
Tanzania101 participantsStarted 2019-09-24
Plain-language summary
A Tanzanian pilot study to test the feasibility of using the Cytospongeâ„¢ device - a less-invasive endoscopy alternative - for research on esophageal squamous cell carcinoma in African settings.
Who can participate
Age range30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 30 years or older.
* Resident of Kilimanjaro Region for 10 years or more.
Exclusion Criteria:
* 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.
What they're measuring
1
Prevalence of any-grade of esophageal dysplasia
Timeframe: 6 months
2
Distribution of acceptability scores
Timeframe: After cytosponge swallow
Trial details
NCT IDNCT04090554
SponsorInternational Agency for Research on Cancer