Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT03529669
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2018-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Somnath.Mukherjee@ouh.nhs.uk', 'phone': '01865 617018', 'title': 'Dr Somnath Mukherjee', 'organization': 'Oxford University Hospitals NHS Trust'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from Cytosponge administration to completion of the 2 week telephone follow up interview.', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Cytosponge™', 'description': 'All participants will receive the Cytosponge™ device.\n\nCytosponge™ 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.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 3, 'seriousNumAtRisk': 39, 'deathsNumAffected': 3, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Sore throat', 'notes': 'Starting on the day of Cytosponge procedure and persisting past the end of study. Classified as CTCAE grade 1 and probably not related to the procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'notes': 'Starting 7 days following the Cytosponge procedure and resolving within 7 days. Classified as CTCAE grade 1 and probably not related to the procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'notes': 'Starting on the day of the Cytosponge procedure and resolving within 3 days. Classified as CTCAE grade 1 and possibly related to the procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute cholecystitis', 'notes': 'Diagnosed 5 days after the Cytosponge procedure and persisting past the end of study. Defined as probably not related to the Cytosponge procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'notes': 'Diagnosed 7 days after the Cytosponge procedure and persisting past the end of study. Defined as probably not related to the Cytosponge procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Completion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cytosponge™', 'description': 'All participants will receive the Cytosponge™ device.\n\nCytosponge™ 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 following intervention', 'description': 'The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals who attempted to carry out the Cytosponge procedure.'}, {'type': 'SECONDARY', 'title': 'Safety; Number of SAEs Related to the Device Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cytosponge™', 'description': 'All participants will receive the Cytosponge™ device.\n\nCytosponge™ 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Two week follow up', 'description': 'All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants who successfully swallowed the Cytosponge device (i.e. 2 participants in the total population of 41 did not manage to do so).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cytosponge™', 'description': 'All participants will receive the Cytosponge™ device.\n\nCytosponge™ 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From sample taken from Cytosponge™ on day of intervention', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cytosponges suitable for biomarker analysis (i.e. 1 of the 39 swallowed devices was not analysed).'}, {'type': 'SECONDARY', 'title': 'Acceptance Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cytosponge™', 'description': 'All participants will receive the Cytosponge™ device.\n\nCytosponge™ 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 after questionnaire completion', 'description': 'Percentage of eligible patients approached who consented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 101 individuals who were initially identified as being eligible for CYTOFLOC, 96 were approached for consent to participate.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Would be Prepared to Repeat the Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cytosponge™', 'description': 'All participants will receive the Cytosponge™ device.\n\nCytosponge™ 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 after questionnaire completion', 'description': '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).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who successfully completed the Cytosponge procedure (out of a total of 41 who attempted it).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cytosponge™', 'description': 'All participants will receive the Cytosponge™ device.\n\nCytosponge™ 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cytosponge™', 'description': 'All participants will receive the Cytosponge™ device.\n\nCytosponge™ 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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68.32', 'spread': '10.28', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Dysphagia level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Able to eat normal diet / no dysphagia', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Able to swallow some solid foods', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Able to swallow only semi-solid foods', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chemo-radiotherapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Definitive chemo-radiotherapy', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Neo-adjuvant chemo-radiotherapy', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumour site', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Oesophagogastric junction', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Lower thoracic oesophagus', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Middle thoracic oesophagus', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Upper thoracic oesophagus', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumour type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Adenocarcinoma', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Squamous cell carcinoma', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'WHO performance status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': '0 = Able to carry out normal activity without restriction', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '1 = Restricted in strenuous activity but ambulatory and able to carry out light work', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-20', 'size': 1425143, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-19T09:49', 'hasProtocol': True}, {'date': '2020-04-22', 'size': 491232, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-04T06:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2018-02-26', 'resultsFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-28', 'studyFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion Rate', 'timeFrame': 'Day 1 following intervention', 'description': 'The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.'}], 'secondaryOutcomes': [{'measure': 'Safety; Number of SAEs Related to the Device Procedure', 'timeFrame': 'Two week follow up', 'description': 'All serious adverse effects related to the procedure, including bleeding (requiring transfusion) and perforation.'}, {'measure': 'Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality)', 'timeFrame': 'From sample taken from Cytosponge™ on day of intervention', 'description': '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.'}, {'measure': 'Acceptance Rate', 'timeFrame': 'Day 1 after questionnaire completion', 'description': 'Percentage of eligible patients approached who consented.'}, {'measure': 'Number of Patients Who Would be Prepared to Repeat the Procedure', 'timeFrame': 'Day 1 after questionnaire completion', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Oesophageal Cancer', 'Gastrointestinal'], 'conditions': ['Oesophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '36187722', 'type': 'DERIVED', 'citation': "Jones 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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nCytosponge™ 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.\n\nThe 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.\n\nUp to fifty patients will be recruited to the trial across 11 sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, Age \\>/=16 years who\n\n 1. have undergone pre-operative CRT as treatment for oesophageal cancer and due to undergo oesophagectomy or\n 2. have undergone definitive CRT as treatment for oesophageal cancer\n2. 4-16 weeks post completion of CRT\n3. Dysphagia score 0-2 (Mellow Scale)\\*\n4. Able to swallow tablets\n5. Physiologically fit for endoscopy\n6. Written (signed and dated) informed consent\n7. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.\n\nExclusion Criteria:\n\n1. Known to have oesophageal varices or stricture requiring dilatation of the oesophagus.\n2. Unable to temporarily discontinue anticoagulation therapy/medication prior to their procedure\\*\n3. Oesophageal stent\n4. 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.\n\n * 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.'}, 'identificationModule': {'nctId': 'NCT03529669', 'acronym': 'CYTOFLOC', 'briefTitle': 'Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Evaluation of a Non-Endoscopic Immunocytological Device (Cytosponge™) for Post Chemo-radiotherapy Surveillance in Patients With Oesophageal Cancer -a Feasibility Study.', 'orgStudyIdInfo': {'id': 'OCTO_068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cytosponge™', 'description': 'All participants will receive the Cytosponge™ device.', 'interventionNames': ['Device: Cytosponge™']}], 'interventions': [{'name': 'Cytosponge™', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Cytosponge™']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bodelwyddan', 'country': 'United Kingdom', 'facility': 'Glan Clwyd hospital', 'geoPoint': {'lat': 53.26827, 'lon': -3.50078}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Cancer Institute Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Velindre Cancer Centre', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Castle Hill hospital', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester General hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Metropolitan Borough of Wirral', 'country': 'United Kingdom', 'facility': 'Clatterbridge hospital', 'geoPoint': {'lat': 53.37616, 'lon': -3.10501}}, {'city': 'Milton Keynes', 'country': 'United Kingdom', 'facility': 'Milton Keynes University Hospital', 'geoPoint': {'lat': 52.04172, 'lon': -0.75583}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Churchill hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Prof Somnath Mukherjee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre for Statistics in Medicine', 'class': 'OTHER'}, {'name': 'Cancer Research UK', 'class': 'OTHER'}, {'name': 'University of Cambridge', 'class': 'OTHER'}, {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}