CompletedNot Applicable

Cytosponge™ Feasibility Study in Tanzania

Tanzania101 participantsStarted 2019-09-24

Plain-language 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.

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of any-grade of esophageal dysplasia

Timeframe: 6 months

Distribution of acceptability scores

Timeframe: After cytosponge swallow

Trial details

NCT IDNCT04090554

SponsorInternational Agency for Research on Cancer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-20

View on ClinicalTrials.gov More Esophageal Diseases trials

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.