Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of a Non-Endoscopic Immunocytological Device (Cytosponge™) for Post Chemo-radiotherapy Surveillance in Patients With Oesophageal Cancer -a Feasibility Study.

Conditions
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Oesophageal Cancer

Intervention / Treatment
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* Device: Cytosponge™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, Age >/=16 years who have undergone pre-operative CRT as treatment for oesophageal cancer and due to undergo oesophagectomy or have undergone definitive CRT as treatment for oesophageal cancer 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. Patients on anti-coagulation therapy are eligible for the study as long as they are considered suitable candidates for endoscopic biopsy (follow local hospital procedures for management of patients on anticoagulation due to undergo endoscopy). If temporary discontinuation of anticoagulation is required, this should be after consultation with the patients clinical care team.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cytosponge™<br>All participants will receive the Cytosponge™ device. | Device: Cytosponge™<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion Rate | The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure. | Day 1 following intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety; Number of SAEs Related to the Device Procedure | All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation. | 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. | From sample taken from Cytosponge™ on day of intervention | 
| Acceptance Rate | Percentage of eligible patients approached who consented. | 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). | Day 1 after questionnaire completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Oesophageal Cancer, Gastrointestinal