Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-02-26 @ 4:16 PM
Study NCT ID:
NCT04467333
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2020-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Giessen Pulmonary Hypertension in Lung Cancer Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2040-01-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary function test measured via Spirometry.', 'timeFrame': '2 years', 'description': 'vital capacity, total lung capacity, forced expiratory volume in one second, functional vital capacity, diffusing capacity for carbon monoxide, arterial partial pressure of oxygen; all measured as % of predicted normal values.'}, {'measure': 'sPAP values measured via Echocardiography.', 'timeFrame': '2 years', 'description': 'systolic pulmonary artery pressure (sPAP) measured in millimetre of mercury (mmHg).'}, {'measure': 'Body mass index.', 'timeFrame': '2 years', 'description': 'weight and height will be combined to report BMI in kg/m\\^2.'}, {'measure': 'Overall Survival and Progression Free Survival measured in days.', 'timeFrame': '2 years', 'description': 'Overall Survival and Progression free survival in days will be determined by Kaplan-Meier Analysis .Measuared in (st) (time from diagnosis to death)'}, {'measure': 'Measurements of the pulmonary artery diameter (PA) and ascending aorta (AA) diameter measured via computed tomography scan. PA and AA will be measured in millimeters.', 'timeFrame': '2 years', 'description': 'PA and AA will be combined to report the PA/AA quotient as indicator for pulmonary hypertension in all lung cancer patients. With a cut off value of ≥ 1 defining pulmonary hypertension.'}, {'measure': '6 Minute Walk Test in meters.', 'timeFrame': '2 years', 'description': 'The 6 minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome.'}, {'measure': 'Modified Medical Research Council Scale (mMRC).', 'timeFrame': '2 years', 'description': 'Scores on the mMRC reach from 0-4, with higher scores indicating greater dyspnea.'}, {'measure': 'chronic obstructive pulmonary disease assessment test (CAT).', 'timeFrame': '2 years', 'description': 'Scores on the CAT reach from 0-40, with higher scores indicating greater dyspnea.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension Due to Lung Diseases and Hypoxia']}, 'referencesModule': {'references': [{'pmid': '29141888', 'type': 'BACKGROUND', 'citation': 'Pullamsetti SS, Kojonazarov B, Storn S, Gall H, Salazar Y, Wolf J, Weigert A, El-Nikhely N, Ghofrani HA, Krombach GA, Fink L, Gattenlohner S, Rapp UR, Schermuly RT, Grimminger F, Seeger W, Savai R. Lung cancer-associated pulmonary hypertension: Role of microenvironmental inflammation based on tumor cell-immune cell cross-talk. Sci Transl Med. 2017 Nov 15;9(416):eaai9048. doi: 10.1126/scitranslmed.aai9048.'}, {'pmid': '40042816', 'type': 'DERIVED', 'citation': 'Rako ZA, Cekay M, Yogeswaran A, Yildiz S, Arndt PF, Kremer N, Schafer S, Janetzko P, Thal BR, Mummert CM, Franken JK, Soethe H, Werner HF, Dumitrascu R, Grimminger F, Ghofrani HA, Pullamsetti SS, Seeger W, Naeije R, Savai R, Eul B, Tello K. Echocardiographic Measure of Right Ventricular-Pulmonary Arterial Coupling Predicts Survival in Lung Cancer. Ann Am Thorac Soc. 2025 Jul;22(7):1071-1078. doi: 10.1513/AnnalsATS.202409-949OC.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the frequency and implications of pulmonary hypertension in lung cancer patients. To do so, data will be collected from all lung cancer patients at the university hospital Giessen. All data will be analyzed for possible hints of pulmonary hypertension as a comorbidity in lung cancer patients. All information will be generated from the regular guidelines based course of treatment and there will be no interventions. This study will serve as a prospective register for all lung cancer patients treated at the university hospital Giessen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Equivalent to the average of patients with lung cancer in Germany.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with lung cancer at the University of Giessen lung Cancer Center.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04467333', 'acronym': 'PHLHR', 'briefTitle': 'Giessen Pulmonary Hypertension in Lung Cancer Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Giessen Pulmonary Hypertension in Lung Cancer Registry', 'orgStudyIdInfo': {'id': 'PH in lung cancer registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All lung cancer patients', 'description': 'There will not be an intervention.', 'interventionNames': ['Other: All lung cancer patients.']}], 'interventions': [{'name': 'All lung cancer patients.', 'type': 'OTHER', 'description': 'There will be no specific interventions. All patients will receive guidelines based therapy of lung cancer and their comorbidities.', 'armGroupLabels': ['All lung cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35392', 'city': 'Giessen', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bastian Eul, MD', 'role': 'CONTACT', 'email': 'bastian.eul@innere.med.uni-giessen.de'}, {'name': 'Michael John Cekay, MD', 'role': 'CONTACT', 'email': 'michael.cekay@innere.med.uni-giessen.de'}, {'name': 'Khodr Tello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'centralContacts': [{'name': 'Bastian Eul, MD', 'role': 'CONTACT', 'email': 'bastian.eul@innere.med.uni-giessen.de', 'phone': '(+49) 0641/985-42371'}, {'name': 'Michael John Cekay, MD', 'role': 'CONTACT', 'email': 'michael.cekay@innere.med.uni-giessen.de'}], 'overallOfficials': [{'name': 'Bastian Eul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JLU Giessen'}, {'name': 'Khodr Tello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JLU Giessen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}