Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-20 @ 7:15 PM
Study NCT ID:
NCT01698151
Status:
UNKNOWN
Last Update Posted:
2016-03-08
First Post:
2012-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis and Treatment of COPD in Primary Care-use of Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-07', 'studyFirstSubmitDate': '2012-09-28', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalization', 'timeFrame': 'December 1, 2015'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic obstructive Pulmonary Disease', 'COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '24886233', 'type': 'DERIVED', 'citation': 'Sondergaard J, Halling A. The PROTECCT-M study: a cohort study investigating associations between novel specific biomarkers, patient-related, healthcare system markers and the trajectory of COPD patients treated in primary care. BMC Pulm Med. 2014 May 20;14:88. doi: 10.1186/1471-2466-14-88.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational study in primary care aiming to validate biomarkers for chronic obstructive pulmonary disease (COPD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in primary care on the Fyn island, Denmark', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40 years old or more,\n* diagnosis of COPD in primary care\n\nExclusion Criteria:\n\n* Major psychiatric illness,\n* inability to visit primary care doctor,\n* inability to understand danish language,'}, 'identificationModule': {'nctId': 'NCT01698151', 'acronym': 'PROTECCT-M', 'briefTitle': 'Prognosis and Treatment of COPD in Primary Care-use of Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Prognosis and Treatment of COPD in Primary Care-use of Biomarkers', 'orgStudyIdInfo': {'id': 'S-20110163'}}, 'contactsLocationsModule': {'locations': [{'zip': '5500', 'city': 'Middelfart', 'state': 'Fyn', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lene Søndergaard, MD', 'role': 'CONTACT', 'email': 'lene-soendergaard@dadlnet.dk', 'phone': '+45 23675570'}], 'facility': 'Nyhegn, Søndergaard, Trabjerg og Vilhelmsen', 'geoPoint': {'lat': 55.50591, 'lon': 9.73054}}, {'zip': '5000', 'city': 'Odense', 'state': 'Fyn', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Henrik K. Laustrup, MD', 'role': 'CONTACT', 'email': 'hl@winsloewsvej.dk', 'phone': '+45 65504001'}], 'facility': 'Lægerne J.B. Winsløws Vej', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '5000', 'city': 'Odense', 'state': 'Fyn', 'status': 'TERMINATED', 'country': 'Denmark', 'facility': 'Peter Larsen', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '5000', 'city': 'Odense C', 'state': 'Fyn', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Peter Larsen, MD', 'role': 'CONTACT', 'phone': '+45 66125130'}], 'facility': 'Peer Kirkebjerg', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '5450', 'city': 'Otterup', 'state': 'Fyn', 'status': 'WITHDRAWN', 'country': 'Denmark', 'facility': 'Lægerne Lærkevej', 'geoPoint': {'lat': 55.51527, 'lon': 10.39756}}, {'zip': '5471', 'city': 'Søndersø', 'state': 'Fyn', 'status': 'WITHDRAWN', 'country': 'Denmark', 'facility': 'Søndersø Lægehus', 'geoPoint': {'lat': 55.48526, 'lon': 10.2554}}, {'zip': '5320', 'city': 'Agedrup', 'status': 'TERMINATED', 'country': 'Denmark', 'facility': 'Lægerne i Bullerup', 'geoPoint': {'lat': 55.43236, 'lon': 10.48879}}, {'zip': '5610', 'city': 'Assens', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Ester Vad, MD', 'role': 'CONTACT', 'email': 'vadiversen@hotmail.com', 'phone': '+45 64711065'}], 'facility': 'Lægehuset Skelvænget', 'geoPoint': {'lat': 55.27023, 'lon': 9.90081}}, {'zip': '5792', 'city': 'Årslev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lisbeth Muncke Møller, Cand.med.', 'role': 'CONTACT', 'email': 'nrlyn.lc@gmail.com', 'phone': '+45 65901019'}], 'facility': 'Lægerne i Nr. Lyndelse', 'geoPoint': {'lat': 55.30353, 'lon': 10.46428}}, {'zip': '5560', 'city': 'Årup', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Klaus Roslind, MD', 'role': 'CONTACT', 'email': 'k.roslind@dadlnet.dk', 'phone': '+45 6443 1024'}], 'facility': 'Aaruplægerne', 'geoPoint': {'lat': 55.37315, 'lon': 10.04131}}, {'zip': '5600', 'city': 'Faaborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Per Andersen, MD', 'role': 'CONTACT', 'phone': '+45 62610108'}], 'facility': 'Lægerne Lægehuset', 'geoPoint': {'lat': 55.0951, 'lon': 10.24226}}, {'zip': '5600', 'city': 'Faaborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Per Andersen, MD', 'role': 'CONTACT', 'email': 'per.andersen@dadlnet.dk'}], 'facility': 'Per Andersen', 'geoPoint': {'lat': 55.0951, 'lon': 10.24226}}, {'zip': '5854', 'city': 'Gislev', 'status': 'WITHDRAWN', 'country': 'Denmark', 'facility': 'Lægehuset i Gislev', 'geoPoint': {'lat': 55.21811, 'lon': 10.60224}}, {'zip': '5683', 'city': 'Haarby', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lisbeth Johansen, MD', 'role': 'CONTACT', 'email': 'haarbylaegerne@post1.tele.dk', 'phone': '+45 64731616'}], 'facility': 'Haarbylægerne', 'geoPoint': {'lat': 55.22357, 'lon': 10.12268}}, {'zip': '5683', 'city': 'Haarby', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mia Skytte Petersen, MD', 'role': 'CONTACT', 'email': 'mia@halldorgg.com', 'phone': '+45 64732312'}], 'facility': 'Jordløselægerne', 'geoPoint': {'lat': 55.22357, 'lon': 10.12268}}, {'zip': '5874', 'city': 'Hesselager', 'status': 'COMPLETED', 'country': 'Denmark', 'facility': 'Lægerne i Hesselager', 'geoPoint': {'lat': 55.17554, 'lon': 10.74519}}, {'zip': '5874', 'city': 'Hesselager', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Tina Riis Jørgensen, Cand.med.', 'role': 'CONTACT', 'email': 'tinariis@hotmail.com', 'phone': '+45 62271089'}], 'facility': 'Lægerne i Hesselager', 'geoPoint': {'lat': 55.17554, 'lon': 10.74519}}, {'zip': '5300', 'city': 'Kerteminde', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Hanne Nielsen', 'role': 'CONTACT', 'email': 'birkevej.kerteminde@mail.dk', 'phone': '+45 65321743'}], 'facility': 'Lægerne Glenthøj & Nielsen', 'geoPoint': {'lat': 55.44903, 'lon': 10.65769}}, {'zip': '5300', 'city': 'Kerteminde', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Tronegaard-Madsen, MD', 'role': 'CONTACT', 'email': 'surlemont@hotmail.com', 'phone': '+45 65321048'}], 'facility': 'Lægerne Tronegaard-Madsen og Schmidt', 'geoPoint': {'lat': 55.44903, 'lon': 10.65769}}, {'zip': '5300', 'city': 'Kerteminde', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Dorte Ejg Jarbøl, MD', 'role': 'CONTACT', 'email': 'djarbol@health.sdu.dk', 'phone': '+45 22486886'}], 'facility': 'Muusgaarden', 'geoPoint': {'lat': 55.44903, 'lon': 10.65769}}, {'zip': '5772', 'city': 'Kværndrup', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Tina Riis, MD', 'role': 'CONTACT', 'email': 'tinariis@hotmail.com', 'phone': '+45 62271089'}], 'facility': 'Lægerne i Kværndrup', 'geoPoint': {'lat': 55.17752, 'lon': 10.52549}}, {'zip': '5500', 'city': 'Middelfart', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jeff Sørensen, MD', 'role': 'CONTACT', 'email': 'laegerneihavnegade@live.dk', 'phone': '+45 64410942'}], 'facility': 'Lægerne i Havnegade', 'geoPoint': {'lat': 55.50591, 'lon': 9.73054}}, {'zip': '5462', 'city': 'Morud', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Elsebeth Lindegaard, MD', 'role': 'CONTACT', 'phone': '+45 65964125'}], 'facility': 'Lægehuset i Morud', 'geoPoint': {'lat': 55.44814, 'lon': 10.18962}}, {'zip': '5800', 'city': 'Nyborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Alice Vesterbjerg, MD', 'role': 'CONTACT', 'email': 'alis@huslaegerne.dk', 'phone': '+45 65310143'}], 'facility': 'Lægerne Nr. Voldgade', 'geoPoint': {'lat': 55.31274, 'lon': 10.78964}}, {'zip': '5800', 'city': 'Nyborg', 'status': 'TERMINATED', 'country': 'Denmark', 'facility': 'Lægerne Nyenstad', 'geoPoint': {'lat': 55.31274, 'lon': 10.78964}}, {'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Nanna Kirkebjeg, MD', 'role': 'CONTACT', 'phone': '+45 66 12 51 30'}], 'facility': 'Bylægen Peer Kirkebjerg & Speciallæge Nanna Kirkebjerg', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Bo Gamborg Nielsen, MD', 'role': 'CONTACT', 'phone': '+4566176600'}], 'facility': 'Læge Bo Gamborg Nielsen', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '5000', 'city': 'Odense C', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Annette Tornøe, MD', 'role': 'CONTACT', 'email': 'a.tornoe@dadlnet.dk', 'phone': '+4565919146'}], 'facility': 'Annette Tornøe', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '5000', 'city': 'Odense C', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Kirsten Wengler, MD', 'role': 'CONTACT', 'email': 'kwengler@dadlnet.dk', 'phone': '+4565919146'}], 'facility': 'Kirsten Wengler', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '5000', 'city': 'Odense C', 'status': 'TERMINATED', 'country': 'Denmark', 'facility': 'Læge Thore Eriksen', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '5000', 'city': 'Odense C', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Agertoft, MD', 'role': 'CONTACT', 'phone': '+66112101'}], 'facility': 'Lægerne Agertoft og Petersen', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '5220', 'city': 'Odense SØ', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Rasmus Dahl Larsen, MD', 'role': 'CONTACT', 'phone': '+45 66179017'}], 'facility': 'Almen Medicinsk Lægeklinik', 'geoPoint': {'lat': 55.35213, 'lon': 10.4801}}, {'zip': '5450', 'city': 'Otterup', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Martin Munk, MD', 'role': 'CONTACT', 'email': 'martinmunk@dadlnet.dk', 'phone': '+45 64821027'}], 'facility': 'Lægerne Banepladsen', 'geoPoint': {'lat': 55.51527, 'lon': 10.39756}}, {'zip': '5750', 'city': 'Ringe', 'status': 'TERMINATED', 'country': 'Denmark', 'facility': 'Lægerne i Østergade', 'geoPoint': {'lat': 55.23828, 'lon': 10.4786}}, {'zip': '5900', 'city': 'Rudkøbing', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Sanne Uhrenholt Andersen', 'role': 'CONTACT', 'email': 'jv@ruddoc.dk', 'phone': '+45 63511700'}], 'facility': 'Lægehuset Rudkøbing I/S', 'geoPoint': {'lat': 54.93639, 'lon': 10.71019}}, {'zip': '5900', 'city': 'Rudkøbing', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jens Stærk Jensen, MD', 'role': 'CONTACT', 'email': 'laegerne@oerstedsgade.dk', 'phone': '+45 62515141'}], 'facility': 'Lægerne Ørstedsgade', 'geoPoint': {'lat': 54.93639, 'lon': 10.71019}}, {'zip': '5700', 'city': 'Svendborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Henrik Lund, MD', 'role': 'CONTACT', 'email': 'henrik.lund@dadlnet.dk', 'phone': '+45 62214518'}], 'facility': 'Lægerne Toldbodvej', 'geoPoint': {'lat': 55.05982, 'lon': 10.60677}}, {'zip': '5492', 'city': 'Vissenbjerg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Thomas Kanstrup, MD', 'role': 'CONTACT', 'email': '5492vissenbjerg@gmail.com', 'phone': '+45 64471077'}], 'facility': 'Lægehuset i Vissenbjerg', 'geoPoint': {'lat': 55.38482, 'lon': 10.13784}}], 'centralContacts': [{'name': 'Frans Boch Waldorff, MD, PhD', 'role': 'CONTACT', 'email': 'fwaldorff@health.sdu.dk', 'phone': '+45 6550 7643'}, {'name': 'Helle Reintoft Andersen', 'role': 'CONTACT', 'email': 'hereandersen@health.sdu.dk', 'phone': '+45 6550 3830'}], 'overallOfficials': [{'name': 'Frans Boch Waldorff, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ministry of Science, Technology and Innovation, Denmark', 'class': 'OTHER_GOV'}, {'name': 'Region of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Frans Boch Waldorff', 'investigatorAffiliation': 'University of Southern Denmark'}}}}