Oesophageal Cancer
Conditions
Keywords
Cancer, Oesophageal Cancer, Gastrointestinal
Brief 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.
Interventions
DEVICECytosponge™
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.
Sponsors
Centre for Statistics in Medicine
Cancer Research UK
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
University of Oxford
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate | Day 1 following intervention | The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance Rate | Day 1 after questionnaire completion | Percentage of eligible patients approached who consented. |
| Safety; Number of SAEs Related to the Device Procedure | Two week follow up | All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation. |
| Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality) | From sample taken from Cytosponge™ on day of intervention | Quality of material obtained from Cytosponge™ test was centrally analysed at Cambridge (cellularity, yield and quality of extracted DNA as measure of quality). A positive Cytosponge™ result was defined as presence of positive cytological atypia, atypia of uncertain significance, and/or p53 aberrant. |
| Number of Patients Who Would be Prepared to Repeat the Procedure | Day 1 after questionnaire completion | Number of patients who have successfully undergone the procedure & would be prepared to accept the procedure repeatedly if it was to be used for follow-up (data captured through questionnaire after procedure). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cytosponge™ All participants will receive the Cytosponge™ device.
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. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Cytosponge™ | — |
|---|---|---|
| Age, Continuous | 68.32 years STANDARD_DEVIATION 10.28 | — |
| Chemo-radiotherapy Definitive chemo-radiotherapy | 28 Participants | — |
| Chemo-radiotherapy Neo-adjuvant chemo-radiotherapy | 13 Participants | — |
| Dysphagia level Able to eat normal diet / no dysphagia | 27 Participants | — |
| Dysphagia level Able to swallow only semi-solid foods | 2 Participants | — |
| Dysphagia level Able to swallow some solid foods | 12 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 33 Participants | — |
| Tumour site Lower thoracic oesophagus | 22 Participants | — |
| Tumour site Middle thoracic oesophagus | 8 Participants | — |
| Tumour site Oesophagogastric junction | 4 Participants | — |
| Tumour site Upper thoracic oesophagus | 7 Participants | — |
| Tumour type Adenocarcinoma | 16 Participants | — |
| Tumour type Squamous cell carcinoma | 25 Participants | — |
| WHO performance status 0 = Able to carry out normal activity without restriction | 26 Participants | — |
| WHO performance status 1 = Restricted in strenuous activity but ambulatory and able to carry out light work | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 39 |
| other Total, other adverse events | 3 / 39 |
| serious Total, serious adverse events | 1 / 39 |
Outcome results
Primary
Completion Rate
The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.
Time frame: Day 1 following intervention
Population: Individuals who attempted to carry out the Cytosponge procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cytosponge™ | Completion Rate | 39 Participants |
Secondary
Acceptance Rate
Percentage of eligible patients approached who consented.
Time frame: Day 1 after questionnaire completion
Population: Of the 101 individuals who were initially identified as being eligible for CYTOFLOC, 96 were approached for consent to participate.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cytosponge™ | Acceptance Rate | 41 Participants |
Secondary
Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality)
Quality of material obtained from Cytosponge™ test was centrally analysed at Cambridge (cellularity, yield and quality of extracted DNA as measure of quality). A positive Cytosponge™ result was defined as presence of positive cytological atypia, atypia of uncertain significance, and/or p53 aberrant.
Time frame: From sample taken from Cytosponge™ on day of intervention
Population: Cytosponges suitable for biomarker analysis (i.e. 1 of the 39 swallowed devices was not analysed).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cytosponge™ | Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality) | 9 Participants |
Secondary
Number of Patients Who Would be Prepared to Repeat the Procedure
Number of patients who have successfully undergone the procedure & would be prepared to accept the procedure repeatedly if it was to be used for follow-up (data captured through questionnaire after procedure).
Time frame: Day 1 after questionnaire completion
Population: Participants who successfully completed the Cytosponge procedure (out of a total of 41 who attempted it).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cytosponge™ | Number of Patients Who Would be Prepared to Repeat the Procedure | 37 Participants |
Secondary
Safety; Number of SAEs Related to the Device Procedure
All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation.
Time frame: Two week follow up
Population: The participants who successfully swallowed the Cytosponge device (i.e. 2 participants in the total population of 41 did not manage to do so).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cytosponge™ | Safety; Number of SAEs Related to the Device Procedure | 2 events |