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

Primary Purpose

Oesophageal Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cytosponge™
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Oesophageal Cancer focused on measuring Cancer, Oesophageal Cancer, Gastrointestinal

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Glan Clwyd hospital
  • Cancer Institute Bristol
  • Addenbrooke's Hospital
  • Velindre Cancer Centre
  • Castle Hill hospital
  • Leicester General hospital
  • The Christie
  • Milton Keynes University Hospital
  • Churchill hospital
  • University Hospital Southampton
  • Clatterbridge hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cytosponge™

Arm Description

All participants will receive the Cytosponge™ device.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety; Number of SAEs Related to the Device Procedure
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)
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
Percentage of eligible patients approached who consented.
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).

Full Information

First Posted
February 26, 2018
Last Updated
March 28, 2022
Sponsor
University of Oxford
Collaborators
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, Cambridge University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03529669
Brief Title
Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer
Acronym
CYTOFLOC
Official Title
Evaluation of a Non-Endoscopic Immunocytological Device (Cytosponge™) for Post Chemo-radiotherapy Surveillance in Patients With Oesophageal Cancer -a Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
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, Cambridge University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophageal Cancer
Keywords
Cancer, Oesophageal Cancer, Gastrointestinal

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cytosponge™
Arm Type
Experimental
Arm Description
All participants will receive the Cytosponge™ device.
Intervention Type
Device
Intervention Name(s)
Cytosponge™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion Rate
Description
The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.
Time Frame
Day 1 following intervention
Secondary Outcome Measure Information:
Title
Safety; Number of SAEs Related to the Device Procedure
Description
All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation.
Time Frame
Two week follow up
Title
Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality)
Description
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.
Time Frame
From sample taken from Cytosponge™ on day of intervention
Title
Acceptance Rate
Description
Percentage of eligible patients approached who consented.
Time Frame
Day 1 after questionnaire completion
Title
Number of Patients Who Would be Prepared to Repeat the Procedure
Description
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).
Time Frame
Day 1 after questionnaire completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Somnath Mukherjee
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glan Clwyd hospital
City
Bodelwyddan
Country
United Kingdom
Facility Name
Cancer Institute Bristol
City
Bristol
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
Country
United Kingdom
Facility Name
Castle Hill hospital
City
Hull
Country
United Kingdom
Facility Name
Leicester General hospital
City
Leicester
Country
United Kingdom
Facility Name
The Christie
City
Manchester
Country
United Kingdom
Facility Name
Milton Keynes University Hospital
City
Milton Keynes
Country
United Kingdom
Facility Name
Churchill hospital
City
Oxford
Country
United Kingdom
Facility Name
University Hospital Southampton
City
Southampton
Country
United Kingdom
Facility Name
Clatterbridge hospital
City
Wirral
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36187722
Citation
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.
Results Reference
derived

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Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer

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