This is a feasibility study testing the use of the Cytosponge™ device in patients with known oesophageal cancer treated with pre-operative or definitive chemoradiation. All participants will receive one Cytosponge™ procedure at one time-point within 4-16 weeks after completion of chemoradiotherapy.
In this feasibility study, we are investigating a novel way to test for remaining or reoccurring oesophageal cancer following chemoradiotherapy. The technique used to test this is called a Cytosponge™. We will be testing the use of the Cytosponge™ to determine completion rate, safety and acceptability of the procedure. Cytosponge™ is a capsule-sized device which contains an expandable, spherical mesh which is attached to a string. The capsule dissolves in the stomach after swallowing, releasing the sponge which is then retrieved by gently pulling the string after five minutes. As the sponge is pulled out it collects the cells from the lining of the gullet. The Cytosponge™ will be processed for evidence of residual cancer through analysis of cellular atypia and molecular biomarkers. Where available, the results will be compared with histology. Up to fifty patients will be recruited to the trial across 11 sites.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
41
Cytosponge™ is a capsule-sized device which contains an expandable, spherical mesh which is attached to a string. The capsule dissolves in the stomach after swallowing, releasing the sponge which is then retrieved by gently pulling the string after five minutes. As the sponge is pulled out it collects the cells from the lining of the gullet.
Glan Clwyd hospital
Bodelwyddan, United Kingdom
Cancer Institute Bristol
Bristol, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Velindre Cancer Centre
Completion Rate
The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.
Time frame: Day 1 following intervention
Safety; Number of SAEs Related to the Device Procedure
All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation.
Time frame: Two week follow up
Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality)
Quality of material obtained from Cytosponge™ test was centrally analysed at Cambridge (cellularity, yield and quality of extracted DNA as measure of quality). A positive Cytosponge™ result was defined as presence of positive cytological atypia, atypia of uncertain significance, and/or p53 aberrant.
Time frame: From sample taken from Cytosponge™ on day of intervention
Acceptance Rate
Percentage of eligible patients approached who consented.
Time frame: Day 1 after questionnaire completion
Number of Patients Who Would be Prepared to Repeat the Procedure
Number of patients who have successfully undergone the procedure \& would be prepared to accept the procedure repeatedly if it was to be used for follow-up (data captured through questionnaire after procedure).
Time frame: Day 1 after questionnaire completion
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Cardiff, United Kingdom
Castle Hill hospital
Hull, United Kingdom
Leicester General hospital
Leicester, United Kingdom
The Christie
Manchester, United Kingdom
Clatterbridge hospital
Metropolitan Borough of Wirral, United Kingdom
Milton Keynes University Hospital
Milton Keynes, United Kingdom
Churchill hospital
Oxford, United Kingdom
...and 1 more locations