Cytosponge™ Feasibility Study in Tanzania (CytoSCCAPE)
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|ClinicalTrials.gov Identifier: NCT04090554|
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Diseases Esophagus SCC||Device: Cytosponge™||Not Applicable|
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 attached to the suture which is held onto by the patient or nurse (and which is affixed to a card preventing inadvertent swallowing of the suture). In the stomach the capsule is left for up to 5 minutes where it dissolves allowing the sponge to expand to its full size. It is then withdrawn using the suture, and as it does so collects cells from the lining of the oesophagus. After retrieval the Cytosponge™ containing the cytological specimen placed in preservative fluid. The typical cell yield of the procedure is 250,000. These cells are used to prepare a clot which is fixed with formalin and embedded in paraffin for sectioning and slide preparation. Slides are then examined under a microscope for pathological diagnosis and characterisation. This device was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 2008 and is a Class 1 device according to European Medical Devices 93/42/EEC as implemented in the United Kingdom by The Medical Devices Regulations 2002 (SI No 618).
Healthy adult (>30 years) volunteers will be recruited during routine visits to the Majengo Healthcare Centre in Moshi, Tanzania where they will be informed of the study and invited to participate. Their participation will then involve the following:
- Completing a short lifestyle questionnaire.
- Swallowing the Cytosponge™ device to collect cells from their oesophagus.
- Being contacted by telephone 7-days post procedure to assess acceptability.
The following endpoints will be investigated:
- Response rate of participants invited to swallow device.
- Proportion of participants able to swallow the device within three attempts and number of attempts taken (frequency distribution of 1, 2 and 3 attempts).
- Post-swallow acceptability of device as per a previously employed satisfaction score (graded 0-10)
- Proportion of collected sponges successfully processed into paraffin blocks.
- Prevalence of ESD as determined by examination by a trained pathologist.
- Prevalence of benign oesophageal pathologies (inflammation, candidiasis, eosinophilic oesophagitis).
Extended (subject to future funding):
- Prevalence of positivity for antibodies against chemical exposures and proliferation markers.
- DNA yield from cells collected from the device.
- DNA methylation profiles.
- Genetic mutations in candidate cancer-relevant gene panel.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Healthy community volunteers will be invited to participate in the study , complete and questionnaire and swallow the cytosponge. Participation rates and acceptability of device administration will be assess in this single group.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Esophageal Squamous Cell Carcinoma African Prevention Research (ESCCAPE) Cytosponge™ Feasibility Study|
|Estimated Study Start Date :||September 24, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Single intervention arm of feasibility study
The device consists of a spherical mesh enclosed in a gelatine capsule and attached to a string. The capsule is swallowed and allowed to reach the stomach . In the stomach the capsule is left for up to 5 minutes where it dissolves allowing the sponge to expand to its full size. It is then withdrawn using the suture, and as it does so collects cells from the lining of the oesophagus.
- Prevalence of any-grade of esophageal dysplasia [ Time Frame: 6 months ]
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.
- Distribution of acceptability scores [ Time Frame: After cytosponge swallow ]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.
- Prevalence of other benign esophageal pathologies [ Time Frame: 6 months ]Prevalence of the presence (yes/no) of oOther benign esophageal pathologies including candidiasis, esophagitis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090554
|Contact: Valerie A McCormack, PhD||+33 4 72 73 85 firstname.lastname@example.org|
|Contact: Daniel RS Middleton, PhD||+33 472 738 email@example.com|
|Principal Investigator:||Valerie A McCormack, PhD||International Agency for Research on Cancer|
|Principal Investigator:||Venance Maro, MD||Kilimanjaro Clinical Research Institute|