Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer
NCT ID: NCT03529669
Last Updated: 2022-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2018-04-18
2020-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Cytosponge™
All participants will receive the Cytosponge™ device.
Cytosponge™
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.
Interventions
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Cytosponge™
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.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
16 Years
ALL
No
Sponsors
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Centre for Statistics in Medicine
OTHER
Cancer Research UK
OTHER
University of Cambridge
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Prof Somnath Mukherjee
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Glan Clwyd hospital
Bodelwyddan, , United Kingdom
Cancer Institute Bristol
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Velindre Cancer Centre
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
University Hospital Southampton
Southampton, , United Kingdom
Countries
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References
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Jones CM, O'Connor H, O'Donovan M, Hayward D, Blasko A, Harman R, Malhotra S, Debiram-Beecham I, Alias B, Bailey A, Bateman A, Crosby TDL, Falk S, Gollins S, Hawkins MA, Kadri S, Levy S, Radhakrishna G, Roy R, Sripadam R, Fitzgerald RC, Mukherjee S. Use of a non-endoscopic immunocytological device (Cytosponge) for post chemoradiotherapy surveillance in patients with oesophageal cancer in the UK (CYTOFLOC): A multicentre feasibility study. EClinicalMedicine. 2022 Sep 23;53:101664. doi: 10.1016/j.eclinm.2022.101664. eCollection 2022 Nov.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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OCTO_068
Identifier Type: -
Identifier Source: org_study_id
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