Trial Outcomes & Findings for Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer (NCT NCT03529669)

NCT ID: NCT03529669

Last Updated: 2022-07-25

Results Overview

The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: Day 1 following intervention
• Results posted on: 2022-07-25

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Cytosponge™ n=41 Participants 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.
Age, Continuous	68.32 years STANDARD_DEVIATION 10.28 • n=41 Participants
Sex: Female, Male Female	8 Participants n=41 Participants
Sex: Female, Male Male	33 Participants n=41 Participants
Dysphagia level Able to eat normal diet / no dysphagia	27 Participants n=41 Participants
Dysphagia level Able to swallow some solid foods	12 Participants n=41 Participants
Dysphagia level Able to swallow only semi-solid foods	2 Participants n=41 Participants
Chemo-radiotherapy Definitive chemo-radiotherapy	28 Participants n=41 Participants
Chemo-radiotherapy Neo-adjuvant chemo-radiotherapy	13 Participants n=41 Participants
Tumour site Oesophagogastric junction	4 Participants n=41 Participants
Tumour site Lower thoracic oesophagus	22 Participants n=41 Participants
Tumour site Middle thoracic oesophagus	8 Participants n=41 Participants
Tumour site Upper thoracic oesophagus	7 Participants n=41 Participants
Tumour type Adenocarcinoma	16 Participants n=41 Participants
Tumour type Squamous cell carcinoma	25 Participants n=41 Participants
WHO performance status 0 = Able to carry out normal activity without restriction	26 Participants n=41 Participants
WHO performance status 1 = Restricted in strenuous activity but ambulatory and able to carry out light work	15 Participants n=41 Participants

PRIMARY outcome

Timeframe: Day 1 following intervention

Population: Individuals who attempted to carry out the Cytosponge procedure.

The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.

Outcome measures

Measure

Cytosponge™ n=41 Participants 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.

Completion Rate

39 Participants

SECONDARY outcome

Timeframe: 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).

All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation.

Outcome measures

Measure

Cytosponge™ n=39 Participants 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.

Safety; Number of SAEs Related to the Device Procedure

2 events

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure

Cytosponge™ n=38 Participants 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.

Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality)

9 Participants

SECONDARY outcome

Timeframe: 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.

Percentage of eligible patients approached who consented.

Outcome measures

Measure

Cytosponge™ n=96 Participants 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.

Acceptance Rate

41 Participants

SECONDARY outcome

Timeframe: Day 1 after questionnaire completion

Population: Participants who successfully completed the Cytosponge procedure (out of a total of 41 who attempted it).

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).

Outcome measures

Measure

Cytosponge™ n=39 Participants 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.

Number of Patients Who Would be Prepared to Repeat the Procedure

37 Participants

Adverse Events

Cytosponge™

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Measure	Cytosponge™ n=39 participants at risk 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.
Hepatobiliary disorders Acute cholecystitis	2.6% 1/39 • Adverse events were collected from Cytosponge administration to completion of the 2 week telephone follow up interview. The Cytosponge is an Investigational Medical Device \& therefore additional categorisation of Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) was required. Of the 41 trial participants, 39 successfully swallowed the Cytosponge device and were therefore evaluable for Adverse Events.
Infections and infestations Pneumonia	2.6% 1/39 • Adverse events were collected from Cytosponge administration to completion of the 2 week telephone follow up interview. The Cytosponge is an Investigational Medical Device \& therefore additional categorisation of Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) was required. Of the 41 trial participants, 39 successfully swallowed the Cytosponge device and were therefore evaluable for Adverse Events.

Other adverse events

Measure	Cytosponge™ n=39 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Sore throat	2.6% 1/39 • Adverse events were collected from Cytosponge administration to completion of the 2 week telephone follow up interview. The Cytosponge is an Investigational Medical Device \& therefore additional categorisation of Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) was required. Of the 41 trial participants, 39 successfully swallowed the Cytosponge device and were therefore evaluable for Adverse Events.
Gastrointestinal disorders Dysphagia	2.6% 1/39 • Adverse events were collected from Cytosponge administration to completion of the 2 week telephone follow up interview. The Cytosponge is an Investigational Medical Device \& therefore additional categorisation of Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) was required. Of the 41 trial participants, 39 successfully swallowed the Cytosponge device and were therefore evaluable for Adverse Events.
Gastrointestinal disorders Dyspepsia	2.6% 1/39 • Adverse events were collected from Cytosponge administration to completion of the 2 week telephone follow up interview. The Cytosponge is an Investigational Medical Device \& therefore additional categorisation of Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) was required. Of the 41 trial participants, 39 successfully swallowed the Cytosponge device and were therefore evaluable for Adverse Events.

Additional Information

Dr Somnath Mukherjee

Oxford University Hospitals NHS Trust

Phone: 01865 617018

Email: Somnath.Mukherjee@ouh.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee NHS Organisations shall not publish or otherwise disseminate the conclusions of the Study, including all or any part of the Results of the Study without prior written consent of the Sponsor, such consent not to be unreasonably withheld. Any publication or other dissemination of the conclusions of the Study by NHS Organisations shall not occur until the Sponsor has published the conclusions of the Study \& shall refer to publication by the Sponsor in such form as the Sponsor may reasonably direct.
• Publication restrictions are in place

Restriction type: OTHER