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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

Tracking Information
First Submitted Date  ICMJE February 26, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date February 21, 2020
Actual Study Start Date  ICMJE April 18, 2018
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer
Official Title  ICMJE Evaluation of a Non-Endoscopic Immunocytological Device (Cytosponge™) for Post Chemo-radiotherapy Surveillance in Patients With Oesophageal Cancer -a Feasibility Study.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Oesophageal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Cytosponge™
All participants will receive the Cytosponge™ device.
Intervention: Device: Cytosponge™
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2020)
42
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
50
Actual Study Completion Date  ICMJE January 30, 2020
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529669
Other Study ID Numbers  ICMJE OCTO_068
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Prof Somnath Mukherjee University of Oxford
PRS Account University of Oxford
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP