Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-30 @ 9:42 AM
Study NCT ID:
NCT04558333
Status:
TERMINATED
Last Update Posted:
2024-05-03
First Post:
2020-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012059', 'term': 'Rejection, Psychology'}, {'id': 'D055031', 'term': 'Primary Graft Dysfunction'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'the first 72 hours after transplantation cell free DNA will be collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'lack of resources (personnel and budget)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation.', 'timeFrame': 'up to 520 weeks', 'description': 'death'}], 'secondaryOutcomes': [{'measure': 'Secondary objectives are obtaining information on the development of (Primary graft development) PGD in relationship to respiratory viruses, genetic profile and exhaled breath in patients and (if possible donors) after human lung transplantation.', 'timeFrame': 'from transplantation till 72 hours after surgery', 'description': 'PGD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Transplant Failure and Rejection', 'Primary Graft Dysfunction']}, 'descriptionModule': {'briefSummary': 'Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.', 'detailedDescription': 'At specific time points (according to protocol) exhaled breath, blood specimens, bronchoalveolar lavage and biopsies will be collected. These will be analyzed in an attempt to identify possible biomarkers that will predict the development of PGD and/or CLAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all lung transplant recipients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all lung transplant recipients \\> 18 years signed ICF (informed consent form)\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04558333', 'briefTitle': 'CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation', 'orgStudyIdInfo': {'id': 'CLAD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LTx (lung transplant) patients', 'description': 'identification of possible biomarkers', 'interventionNames': ['Other: blood and exhaled breath specimens']}], 'interventions': [{'name': 'blood and exhaled breath specimens', 'type': 'OTHER', 'description': 'identification of possible biomarkers', 'armGroupLabels': ['LTx (lung transplant) patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'overallOfficials': [{'name': 'Thérèse Lapperre, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Lapperre', 'investigatorFullName': 'Therese Lapperre', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}