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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529669
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : February 21, 2020
Sponsor:
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
Information provided by (Responsible Party):
University of Oxford

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oesophageal Cancer Device: Cytosponge™ Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluation of a Non-Endoscopic Immunocytological Device (Cytosponge™) for Post Chemo-radiotherapy Surveillance in Patients With Oesophageal Cancer -a Feasibility Study.
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : January 30, 2020
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Completion Rate [ Time Frame: Day 1 following intervention ]
    The proportion of consented, evaluable patients successfully undergoing Cytosponge™ will be presented, with the corresponding 95% confidence interval. The proportion will be calculated overall and separately for those having definitive chemoradiotherapy (dCRT) and neo-adjuvant chemoradiotherapy (naCRT).


Secondary Outcome Measures :
  1. Safety; number of SAEs related to the device procedure [ Time Frame: Two week follow up ]
    All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation

  2. Suitability of sample for biomarker analysis [ Time Frame: Up to 2 years ]
    Quality of material obtained from Cytosponge™ test will be centrally analysed at Cambridge (cellularity, yield and quality of extracted DNA will be used as measure of quality). A positive Cytosponge™ result will be defined as presence of cytological atypia and/or p53 mutation

  3. Acceptance rate [ Time Frame: Day 1 after questionnaire completion ]
    Acceptance rate is broken into two stages: 1) Proportion of eligible patients approached who consent. 2) Proportion 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 will be captured through questionnaire after procedure)


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529669


Locations
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United Kingdom
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
Milton Keynes University Hospital
Milton Keynes, United Kingdom
Churchill hospital
Oxford, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Clatterbridge hospital
Wirral, United Kingdom
Sponsors and Collaborators
University of Oxford
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
Investigators
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Principal Investigator: Prof Somnath Mukherjee University of Oxford
More Information
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03529669    
Other Study ID Numbers: OCTO_068
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Cancer
Oesophageal Cancer
Gastrointestinal
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases