NCT03529669

Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oesophageal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-04-18
• Primary completion: 2020-01-30
• Completion: 2020-01-30
• First posted: 2018-05-18
• Last updated: 2022-07-25
• Results posted: 2022-07-25

Locations

11 sites across 1 country: United Kingdom