CYTOFLOC

FULL TITLE

Evaluation of a Non‐Endoscopic Immunocytological Device (Cytosponge™) for post chemo‐radiotherapy surveillance in patients with oesophageal cancer – a feasibility study

Chief Investigator: Prof Somnath Mukherjee

Sponsor: University of Oxford 

Study design

This is a feasibility study involving patients with known oesophageal cancer treated with pre‐ perative or definitive chemoradiation. All participants will undertake the Cytosponge™ test. 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.

Study Population

Patients who have undergone Chemoradiotherapy for oesophageal cancer

Study Status

Open to recruitment

Target recruitment: 50 evaluable patients

INCLUSION CRITERIA

A patient will be eligible for inclusion in this study if all of the following criteria apply.

1. Male or female, Age ³ 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

A patient will not be eligible for the study if any of the following apply:

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.

Sites

Open sites:

• Churchill Hospital, Oxford
• Addenbrooke’s Hospital, Cambridge
• Castle Hill Hospital, Hull
• University Hospital Southampton, Southampton
• Milton Keynes University Hospital, Milton Keynes
• Bristol Cancer Institute, Bristol
• Glan Clwyd Hospital, North Wales
• Clatterbridge Hospital, Liverpool
• Leicester General Hospital, Leicester
• Velindre Cancer Centre, Cardiff
• Christie Hospital, Manchester

Study Schema

Objectives

• Assessment of completion rate of Cytosponge™ as a diagnostic test post chemo-radiotherapy
• Assessment of safety of Cytosponge™ as a diagnostic test post chemo‐radiotherapy
• Assessment of patient acceptability of Cytosponge™ as a diagnostic test post chemo‐radiotherapy
• Assessment of suitability of Cytosponge™ sample for biomarker analysis
• Evaluation of ctDNA and other circulatory markers in assessment of residual disease post CRT
• Evaluation of the comparative efficacy of Cytosponge™ and post‐treatment biopsy in identifying residual cancer, p53 mutations & other identifiable markers in pre-treatment biopsy sample

Data Submission

Data submission for this trial is via electronic submission of data in OpenClinica

CYTOFLOC Trial Office (OCTO)

Tel: +44 (0)1865 617084

General Enquiries: Tel: +44 (0)1865 227 177

Email: octo-CYTOFLOC@oncology.ox.ac.uk

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