Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer

Oesophageal Cancer Clinical Trial

— CYTOFLOC  

Official title:

Evaluation of a Non-Endoscopic Immunocytological Device (Cytosponge™) for Post Chemo-radiotherapy Surveillance in Patients With Oesophageal Cancer -a Feasibility Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529669
• Other study ID #: OCTO_068
• Status: Completed
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: March 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Oesophageal Cancer

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (6)

Lead Sponsor	Collaborator
University of Oxford	Cambridge University Hospitals NHS Foundation Trust, Cancer Research UK and Medical Research Council Oxford Institute for Radiation Oncology, Centre for Statistics in Medicine, CRUK Population Research Committee, MRC Cancer Cell Unit Hutchison-MRC Research Centre, University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion Rate	The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.	Day 1 following intervention
Secondary	Safety; Number of SAEs Related to the Device Procedure	All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation.	Two week follow up
Secondary	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.	From sample taken from Cytosponge™ on day of intervention
Secondary	Acceptance Rate	Percentage of eligible patients approached who consented.	Day 1 after questionnaire completion
Secondary	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).	Day 1 after questionnaire completion