Oesophageal CancerCYTOFLOCNCT03529669
Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer
A study testing Cytosponge™ in people with Oesophageal Cancer, run by University of Oxford at 11 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Oesophageal Cancer
- What is being tested?
- Cytosponge™
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- 18 Apr 2018to 30 Jan 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites
Glan Clwyd hospital
Bodelwyddan
Cancer Institute Bristol
Bristol
Addenbrooke's Hospital
Cambridge
Velindre Cancer Centre
Cardiff
Castle Hill hospital
Hull
Leicester General hospital
Leicester
The Christie
Manchester
Clatterbridge hospital
Metropolitan Borough of Wirral
Milton Keynes University Hospital
Milton Keynes
Churchill hospital
Oxford
University Hospital Southampton
Southampton
About this study
Official title: 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.
Read the 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.
- Conditions
- Oesophageal Cancer
- Being tested
- Cytosponge™
- Keywords
- Cancer, Oesophageal Cancer, Gastrointestinal
- Medical subject headings
- Esophageal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cytosponge™ | Experimental | All participants will receive the Cytosponge™ device. Receives: Device: Cytosponge™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate
The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.
Measured: Day 1 following intervention
Secondary outcomes (4)
Safety; Number of SAEs Related to the Device Procedure
All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation.
Measured: 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.
Measured: From sample taken from Cytosponge™ on day of intervention
Acceptance Rate
Percentage of eligible patients approached who consented.
Measured: 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).
Measured: Day 1 after questionnaire completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start18 Apr 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Statistics in Medicine, Cancer Research UK, University of Cambridge, Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Prof Somnath Mukherjee, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529669
- Sponsor's protocol ID
- OCTO_068
- Acronym
- CYTOFLOC
- Status last verified
- Mar 2022
- First submitted
- 26 Feb 2018
- Last updated
- 25 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36187722