Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer

NCT03529669 | Completed Results

• 1 other identifier: OCTO_068
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 11

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.

Conditions

Oesophageal Cancer

Keywords

Cancer; Oesophageal Cancer; Gastrointestinal

Outcome Measures

Primary Outcomes (1)

• Completion Rate

  The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.

  Day 1 following intervention

Secondary Outcomes (4)

• Safety; Number of SAEs Related to the Device Procedure

  Two week follow up

• 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

• Acceptance Rate

  Day 1 after questionnaire completion

• Number of Patients Who Would be Prepared to Repeat the Procedure

  Day 1 after questionnaire completion

Study Arms (1)

Cytosponge™

EXPERIMENTAL

All participants will receive the Cytosponge™ device.

Device: Cytosponge™

Interventions

Cytosponge™ DEVICE

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.

Cytosponge™

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• Centre for Statistics in Medicine: collaborator
• Cancer Research UK: collaborator
• University of Cambridge: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (11)

Glan Clwyd hospital

Bodelwyddan, United Kingdom

Location

Cancer Institute Bristol

Bristol, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

Velindre Cancer Centre

Cardiff, United Kingdom

Location

Castle Hill hospital

Hull, United Kingdom

Location

Leicester General hospital

Leicester, United Kingdom

Location

The Christie

Manchester, United Kingdom

Location

Clatterbridge hospital

Metropolitan Borough of Wirral, United Kingdom

Location

Milton Keynes University Hospital

Milton Keynes, United Kingdom

Location

Churchill hospital

Oxford, United Kingdom

Location

University Hospital Southampton

Southampton, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36187722 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Dr Somnath Mukherjee
• Organization: Oxford University Hospitals NHS Trust

Somnath.Mukherjee@ouh.nhs.uk

01865 617018

Study Officials

• Prof Somnath Mukherjee

  University of Oxford

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: May 18, 2018
• Study Start: April 18, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: July 25, 2022
• Results First Posted: July 25, 2022

Record last verified: 2022-03

Locations

GB (11)