Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer (CYTOFLOC)

University of Oxford

Status: Completed

Conditions: Oesophageal Cancer

Treatments: Device: Cytosponge™

Study type: Interventional

Funder types: Other

Identifiers

NCT03529669

OCTO_068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Cytosponge™

Experimental group

Description:

All participants will receive the Cytosponge™ device.

Treatment:

Device: Cytosponge™