Clinical trial NCT03529669: Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer
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
Overall status: COMPLETED
Phase: NA
Conditions: Oesophageal Cancer
Keywords: Cancer
Oesophageal Cancer
Gastrointestinal
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Centre for Statistics in Medicine
name: Cancer Research UK
name: University of Cambridge
name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2018-05-18
Enrollment: 41
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility 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.

Primary outcomes:
measure: Completion Rate
timeFrame: Day 1 following intervention
Secondary outcomes:
measure: Safety; Number of SAEs Related to the Device Procedure
timeFrame: Two week follow up
measure: Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality)
timeFrame: From sample taken from Cytosponge™ on day of intervention
measure: Acceptance Rate
timeFrame: Day 1 after questionnaire completion
measure: Number of Patients Who Would be Prepared to Repeat the Procedure
timeFrame: Day 1 after questionnaire completion
Other outcomes:
Locations:
city: Bodelwyddan
country: United Kingdom
facility: Glan Clwyd hospital
city: Bristol
country: United Kingdom
facility: Cancer Institute Bristol
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Hull
country: United Kingdom
facility: Castle Hill hospital
city: Leicester
country: United Kingdom
facility: Leicester General hospital
city: Manchester
country: United Kingdom
facility: The Christie
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital
city: Oxford
country: United Kingdom
facility: Churchill hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
city: Wirral
country: United Kingdom
facility: Clatterbridge hospital
Study officials:
affiliation: University of Oxford
name: Prof Somnath Mukherjee
role: PRINCIPAL_INVESTIGATOR
References:
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.