Title

CYTOFLOC

Chief Investigator: 
Prof Somnath Mukherjee

Cytosponge™ for post‐chemoradiation surveillance of oesophageal cancer

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

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

Sites

Open sites:

  • Churchill Hospital, Oxford
  • Addenbrooke’s Hospital, Cambridge
  • Castle Hill Hospital, Hull
  • University Hospital Southampton, Southampton
  • Milton Keynes University Hospital, Milton Keynes

Sites in set up:

  • Christie Hospital, Manchester
  • Bristol Cancer Institute, Bristol
  • Velindre, Cardiff
  • Glan Clwyd Hospital, North Wales
  • Clatterbridge Hospital, Liverpool
  • Leicester General Hospital, Leicester

STUDY SCHEMA

 

OBJECTIVES

  1. Assessment of completion rate of Cytosponge™ as a diagnostic test post chemo-radiotherapy
  2. Assessment of safety of Cytosponge™ as a diagnostic test post chemo‐radiotherapy
  3. Assessment of patient acceptability of Cytosponge™ as a diagnostic test post chemo‐radiotherapy
  4. Assessment of suitability of Cytosponge™ sample for biomarker analysis
  5. Evaluation of ctDNA and other circulatory markers in assessment of residual disease post CRT
  6. 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)

CYTOFLOC Trial Office: Tel: +44 (0)1865 617084

CYTOFLOC Registration Service Mon-Fri 9-5 (UK Time): UK Fax: +44(0)1865 617010

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

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

Website: http://www.oncology.ox.ac.uk/research/oncology-clinical-trials-office-octo

 

About Us
We aim to enhance clinical and basic cancer research in Oxford with the ultimate goal of increasing cancer cure rates.
Research
In Oxford, we have a great wealth of broad-ranging expertise and a powerful network of cancer researchers.
Study With Us
Our graduate and postdoctoral training programmes for both scientists and clinicians are internationally recognised.