Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT05549635
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2022-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Database and Biobank of Patients With Hypersensitivity Pneumonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000542', 'term': 'Alveolitis, Extrinsic Allergic'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'There will be collected serum, EDTA plasma and DNA from included subjects.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2022-06-13', 'studyFirstSubmitQcDate': '2022-09-16', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of HP', 'timeFrame': '0 days', 'description': 'MDT-Diagnosis of HP'}, {'measure': 'Exposure to inciting antigen (patient reported)', 'timeFrame': '0 days', 'description': 'Known exposure, as reported by the patient'}, {'measure': 'Exposure to inciting antigen (measurable)', 'timeFrame': '0 days', 'description': 'Measurable exposure, as tested by precipitins'}, {'measure': 'Progression free survival', 'timeFrame': '3 years', 'description': 'Survival without progression'}, {'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'Survival after diagnosis'}], 'secondaryOutcomes': [{'measure': 'Quality of life questionnaires', 'timeFrame': '3 years', 'description': 'SGRQ'}, {'measure': 'Pulmonary function test', 'timeFrame': '3 years', 'description': 'FVC'}, {'measure': 'Pulmonary function test', 'timeFrame': '3 years', 'description': 'DLCO'}, {'measure': 'Imaging', 'timeFrame': '3 years', 'description': 'HRCT scans'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biomarker', 'prognosis', 'diagnosis', 'phenotyping', 'genotyping'], 'conditions': ['Hypersensitivity Pneumonitis']}, 'descriptionModule': {'briefSummary': 'Sub-study of the main Pulmonary Fibrosis Biomarker (PFBIO) cohort (NCT02755441), recruiting patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP). Patients are included for the collection of blood samples and regular clinical data.\n\nThe database and biobank will be available for studies of HP, and can be directly compared to the main PFBIO cohort, which has recruited patients with Idiopathic pulmonary Fibrosis (IPF) since 2016.\n\nBiomarkers will be assessed as diagnostic and prognostic. Further subtyping of HP, based on blood markers (including precipitins) will also be possible with the PFBIO-HP project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients with an MDT-diagnosis of HP are eligible.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of HP at an MDT conference according to the current international guidelines\n* Age of 18 years or older\n* The patients must be capable of giving informed consent\n\nExclusion Criteria:\n\n\\- Unable to sign informed consent'}, 'identificationModule': {'nctId': 'NCT05549635', 'acronym': 'PFBIO-HP', 'briefTitle': 'Database and Biobank of Patients With Hypersensitivity Pneumonitis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Pulmonary Fibrosis Biobank - Hypersensitivity Pneumonitis', 'orgStudyIdInfo': {'id': 'PFBIO-HP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP)', 'description': 'The overall inclusion criteria of patients in the HP cohort are:\n\n* Diagnosis of HP at an MDT conference according to the current international guidelines\n* Age of 18 years or older\n* The patients must be capable of giving informed consent'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'state': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Nils Hoyer, PhD', 'role': 'CONTACT', 'email': 'nils.hoyer@regionh.dk', 'phone': '+45 50589495'}], 'facility': 'Department of respiratory medicine', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'centralContacts': [{'name': 'Nils Hoyer, PhD', 'role': 'CONTACT', 'email': 'nils.hoyer@regionh.dk', 'phone': '+45-3867 4200'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nils Hoyer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nils Hoyer', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}