Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer (CYTOFLOC)

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

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.

Study Overview

• Status: Completed
• Conditions: Oesophageal Cancer
• Intervention / Treatment: Device: Cytosponge™

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bodelwyddan, United Kingdom
    • Glan Clwyd Hospital
  • Bristol, United Kingdom
    • Cancer Institute Bristol
  • Cambridge, United Kingdom
    • Addenbrooke's Hospital
  • Cardiff, United Kingdom
    • Velindre Cancer Centre
  • Hull, United Kingdom
    • Castle Hill Hospital
  • Leicester, United Kingdom
    • Leicester General Hospital
  • Manchester, United Kingdom
    • The Christie
  • Milton Keynes, United Kingdom
    • Milton Keynes University Hospital
  • Oxford, United Kingdom
    • Churchill Hospital
  • Southampton, United Kingdom
    • University Hospital Southampton
  • Wirral, United Kingdom
    • Clatterbridge Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cytosponge™; All participants will receive the Cytosponge™ device.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Cambridge University Hospitals NHS Foundation Trust; Centre for Statistics in Medicine; CRUK Population Research Committee; Cancer Research UK and Medical Research Council Oxford Institute for Radiation Oncology; MRC Cancer Cell Unit Hutchison-MRC Research Centre, University of Cambridge
• Investigators: Principal Investigator: Prof Somnath Mukherjee, University of Oxford

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Oesophageal Cancer; Gastrointestinal
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: OCTO_068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No