Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 12:00 AM
Study NCT ID:
NCT06885905
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Chronic Pulmonary Aspergillosis (CPA) on Health Status and Well-being
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.', 'timeFrame': '30 months', 'description': 'To develop and validate a novel disease-specific health-related quality of life (HRQoL) measure in chronic pulmonary aspergillosis (CPA): The Chronic Pulmonary Aspergillosis Health Assessment Questionnaire (CPA-HAQ)'}], 'secondaryOutcomes': [{'measure': 'Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.', 'timeFrame': '30 months', 'description': 'Testing the usability of a newly developed CPA-HAQ measure.'}, {'measure': 'Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.', 'timeFrame': '30 months', 'description': 'Correlating how HRQoL outcomes relate to existing disease prognostic markers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CPA'], 'conditions': ['Chronic Pulmonary Aspergillosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/capsule/', 'label': 'NHS Health Research Authority'}]}, 'descriptionModule': {'briefSummary': 'To develop and validate a novel disease-specific questionnaire for measuring HRQoL in patients with Chronic Pulmonary Aspergillosis (CPA-HAQ) for use in clinical research, including clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with confirmed Chronic Pulmonary Aspergillosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients \\>/= 18 years old and able to provide informed consent\n2. Patients with a diagnosis of chronic pulmonary aspergillosis\n3. To speak and understand English\n4. Able to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06885905', 'acronym': 'CAPSULE', 'briefTitle': 'Impact of Chronic Pulmonary Aspergillosis (CPA) on Health Status and Well-being', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Impact of Chronic Pulmonary Aspergillosis (CPA) on Health Status and Well-being', 'orgStudyIdInfo': {'id': '23IC8471'}}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 9SY', 'city': 'Dundee', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'David Connell, PhD FRCP Edin', 'role': 'CONTACT', 'email': 'david.connell@nhs.scot', 'phone': 'david.connell@nhs.scot'}, {'name': 'David Connell, PhD FRCP Edin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ninewells Hospital & Medical School', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Dareen Marghlani, MSc', 'role': 'CONTACT', 'email': 'dsm20@ic.ac.uk', 'phone': 'dsm20@ic.ac.uk'}, {'name': 'Anand Shah, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Imperial College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Chris Kosmidis, PhD', 'role': 'CONTACT', 'email': 'chris.kosmidis@manchester.ac.uk', 'phone': 'chris.kosmidis@manchester.ac.u'}, {'name': 'Chris Kosmidis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Manchester NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Dareen Marghlani, MSc', 'role': 'CONTACT', 'email': 'dsm20@ic.ac.uk', 'phone': 'dsm20@ic.ac.uk'}, {'name': 'Anand Shah, PhD', 'role': 'CONTACT', 'email': 's.anand@imperial.ac.uk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}, {'name': 'Tayside Medical Science Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}