Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT05909020
Status:
UNKNOWN
Last Update Posted:
2023-10-03
First Post:
2023-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EVEREST-HN 1: EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-06-14', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inventory and specification for the SYmptom iNput Clinical (SYNC) system', 'timeFrame': 'September 2022 - August 2023', 'description': 'To optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system'}], 'secondaryOutcomes': [{'measure': 'To further explore the current suspected HNC pathway and the language used when discussing symptoms.', 'timeFrame': 'September 2022 - August 2023', 'description': "To understand how clinicians decide subsequent steps for patients referred with suspected HNC, the language patients and clinicians use to describe symptoms and patients' and clinicians' views and experiences of the current diagnostic process for HNC. with a focus on what would work for EVEREST-HN study."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'Can a patient-reported symptom-based risk stratification system improve the suspected head and neck cancer (HNC) pathway?\n\nOur methodology includes six interlinked work packages to deliver our aim, with EVEREST-HN 1 encompassing the first of these and seeking to optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system.', 'detailedDescription': 'The EVEREST-HN pathway should be based on a comprehensive understanding of existing HNC diagnostic pathways and what patients and clinicians value in these. The language used within the EVEREST pathway needs to be accessible and optimal to elicit appropriate information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients Recruitment will aim for variation in age, ethnicity, socio-economic status, presenting symptoms.\n\nClinicians Clinical staff involved in HNC diagnosis. Varying in seniority (consultant, registrar) and specialty (ENT, maxillofacial)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* Adults ≥ 18 years referred via suspected HNC pathway without previous history of HNC\n* Participants willing and able to give informed consent for participation in the study.\n\nClinicians:\n\n* Staff at participating sites involved in the diagnostic pathway for people with suspected HNC.\n\nExclusion Criteria:\n\n* Individuals who do not meet the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT05909020', 'briefTitle': 'EVEREST-HN 1: EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem to Redesign the Suspected Head and Neck Cancer Referral Pathway (Phase 1)', 'orgStudyIdInfo': {'id': 'CCR5683'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Approximately 150 adults referred for suspected HNC will be recruited.', 'interventionNames': ['Other: No intervention.']}, {'label': 'Staff', 'description': 'Approximately 15 ENT and Maxillofacial) clinicians will be recruited.', 'interventionNames': ['Other: No intervention.']}], 'interventions': [{'name': 'No intervention.', 'type': 'OTHER', 'description': 'No intervention.', 'armGroupLabels': ['Patients', 'Staff']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leeds', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Unknown Unknown', 'role': 'CONTACT'}, {'name': 'James Moor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Liverpool', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Shirley Pringle', 'role': 'CONTACT'}, {'name': 'Katharine Davies', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Liverpool University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Luton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nithin George', 'role': 'CONTACT'}, {'name': 'Chrysostomos Tornari', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Luton & Dunstable University Hospital', 'geoPoint': {'lat': 51.87967, 'lon': -0.41748}}, {'city': 'Oxford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Iqbal Mohammed', 'role': 'CONTACT'}, {'name': 'Stuart Winter', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oxford NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'centralContacts': [{'name': 'Sarah Webb', 'role': 'CONTACT', 'email': 'EVEREST-HN@rmh.nhs.uk', 'phone': '0208 915 6666'}], 'overallOfficials': [{'name': 'Vinidh Paleri', 'role': 'STUDY_CHAIR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Leeds', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}