Clinical trial · Interventional
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.
NCT03529669CI-TRIAL-00059850CYTOFLOCcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oesophageal Cancer | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytosponge™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cytosponge™
- description
- All participants will receive the Cytosponge™ device.
- interventionNames
- Device: Cytosponge™
Primary outcomes (1)
- measure
- Completion Rate
- timeFrame
- Day 1 following intervention
- description
- The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.
Secondary outcomes (4)
- measure
- Safety; Number of SAEs Related to the Device Procedure
- timeFrame
- Two week follow up
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJones CM, O'Connor H, O'Donovan M, Hayward D, Blasko A, Harman R, Malhotra S, Debiram-Beecham I, Alias B, Bailey A, Bateman A, Crosby TDL, Falk S, Gollins S, Hawkins MA, Kadri S, Levy S, Radhakrishna G, Roy R, Sripadam R, Fitzgerald RC, Mukherjee S. Use of a non-endoscopic immunocytological device (Cytosponge) for post chemoradiotherapy surveillance in patients with oesophageal cancer in the UK (CYTOFLOC): A multicentre feasibility study. EClinicalMedicine. 2022 Sep 23;53:101664. doi: 10.1016/j.eclinm.2022.101664. eCollection 2022 Nov. PMID 36187722