N/A
Completed N=41
Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer
Source: ClinicalTrials.gov NCT03529669 ↗Enrolled (actual)
41
Serious AEs
2.6%
Results posted
Jul 2022
Primary outcomePrimary: Completion Rate — 39 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion Rate |
39 | — |
| SECONDARY Safety; Number of SAEs Related to the Device Procedure |
2 | — |
| SECONDARY Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality) |
9 | — |
| SECONDARY Acceptance Rate |
41 | — |
| SECONDARY Number of Patients Who Would be Prepared to Repeat the Procedure |
37 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, Age >/=16 years who
- have undergone pre-operative CRT as treatment for oesophageal cancer and due to undergo oesophagectomy or
- have undergone definitive CRT as treatment for oesophageal cancer
- 4-16 weeks post completion of CRT
- Dysphagia score 0-2 (Mellow Scale)*
- Able to swallow tablets
- Physiologically fit for endoscopy
- Written (signed and dated) informed consent
- 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
- Known to have oesophageal varices or stricture requiring dilatation of the oesophagus.
- Unable to temporarily discontinue anticoagulation therapy/medication prior to their procedure*
- Oesophageal stent
- 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.
Data sourced from ClinicalTrials.gov (NCT03529669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.