Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer

Not Applicable

Completed

• Conditions: Oesophageal Cancer
• Interventions: Device: Cytosponge™

• Registration Number: NCT03529669
• Lead Sponsor: University of Oxford

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-26
• Study Start: 2018-04-18
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-18
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Results First Submitted: 2021-11-05
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Results First Posted: 2022-07-25
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Male or female, Age >/=16 years who

   1. have undergone pre-operative CRT as treatment for oesophageal cancer and due to undergo oesophagectomy or
   2. have undergone definitive CRT as treatment for oesophageal cancer

2. 4-16 weeks post completion of CRT

3. Dysphagia score 0-2 (Mellow Scale)*

4. Able to swallow tablets

5. Physiologically fit for endoscopy

6. Written (signed and dated) informed consent

7. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.

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Exclusion Criteria

1. Known to have oesophageal varices or stricture requiring dilatation of the oesophagus.

2. Unable to temporarily discontinue anticoagulation therapy/medication prior to their procedure*

3. Oesophageal stent

4. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cytosponge™	Cytosponge™	All participants will receive the Cytosponge™ device.

Primary Outcome Measures

Name	Time	Method
Completion Rate	Day 1 following intervention	The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.

Secondary Outcome Measures

Name	Time	Method
Safety; Number of SAEs Related to the Device Procedure	Two week follow up	All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation.
Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality)	From sample taken from Cytosponge™ on day of intervention	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.
Acceptance Rate	Day 1 after questionnaire completion	Percentage of eligible patients approached who consented.
Number of Patients Who Would be Prepared to Repeat the Procedure	Day 1 after questionnaire completion	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).

Trial Locations

Locations (11)

The Christie; 🇬🇧 Manchester, United Kingdom

Glan Clwyd hospital; 🇬🇧 Bodelwyddan, United Kingdom

Velindre Cancer Centre; 🇬🇧 Cardiff, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom

Leicester General hospital; 🇬🇧 Leicester, United Kingdom

University Hospital Southampton; 🇬🇧 Southampton, United Kingdom

Milton Keynes University Hospital; 🇬🇧 Milton Keynes, United Kingdom

Churchill hospital; 🇬🇧 Oxford, United Kingdom

Clatterbridge hospital; 🇬🇧 Wirral, United Kingdom

Cancer Institute Bristol; 🇬🇧 Bristol, United Kingdom

Castle Hill hospital; 🇬🇧 Hull, United Kingdom