Clinical trial · Interventional
Cytosponge™ Feasibility Study in Tanzania
Esophageal Squamous Cell Carcinoma African Prevention Research (ESCCAPE) Cytosponge™ Feasibility Study
NCT04090554CI-TRIAL-00053523CytoSCCAPEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Diseases | — | UNRESOLVED | — |
| Esophagus SCC | Esophageal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytosponge™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cytosponge™
- description
- Single intervention arm of feasibility study
- interventionNames
- Device: Cytosponge™
Primary outcomes (2)
- measure
- Prevalence of any-grade of esophageal dysplasia
- timeFrame
- 6 months
- description
- Any grade (low, moderate or high) of dysplasia. The Three-tier grading scheme will be used: grade 1 (low) well-differentiated; grade 2 (intermediate) for moderately differentiated; grade 3 (high) for poorly differentiated.
- measure
- Distribution of acceptability scores
- timeFrame
- After cytosponge swallow
- description
- Device satisfaction rating assessed on a visual analogue scale from 1 to 10, representing the best and worst satisfaction levels, respectively, and a cartoon face was used to assist interpretation of this scale.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMiddleton DRS, Mmbaga BT, O'Donovan M, Abedi-Ardekani B, Debiram-Beecham I, Nyakunga-Maro G, Maro V, Bromwich M, Daudi A, Ngowi T, Minde R, Claver J, Mremi A, Mwasamwaja A, Schuz J, Fitzgerald RC, McCormack V. Minimally invasive esophageal sponge cytology sampling is feasible in a Tanzanian community setting. Int J Cancer. 2021 Mar 1;148(5):1208-1218. doi: 10.1002/ijc.33366. Epub 2020 Nov 21. PMID 33128785