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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.
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
Male or female, Age >/=16 years who
4-16 weeks post completion of CRT
Dysphagia score 0-2 (Mellow Scale)*
Able to swallow tablets
Physiologically fit for endoscopy
Written (signed and dated) informed consent
The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
Exclusion criteria
Known to have oesophageal varices or stricture requiring dilatation of the oesophagus.
Unable to temporarily discontinue anticoagulation therapy/medication prior to their procedure*
Oesophageal stent
Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results.
Primary purpose
Allocation
Interventional model
Masking
41 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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