Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT01949259
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2013-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Learning for Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2013-09-10', 'studyFirstSubmitQcDate': '2013-09-19', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'From radiotherapy until death', 'description': 'Retrospective data will be collected from each included patient from start of radiotherapy until end of study or death (an expected average of 10 years).'}], 'secondaryOutcomes': [{'measure': 'Local control', 'timeFrame': 'From start of treatment until death,', 'description': 'Data will be collected from inclusion in the study until end of study of death (an expected average time frame of 10 years) concerning the local control of this tumour.'}, {'measure': 'Distant metastases', 'timeFrame': 'From treatment until end of study', 'description': 'Data concerning the possible occurence of distant metastases will be collected from each patient from inclusion until end of study or date of death (an expected average time frame of 10 years).'}, {'measure': 'Dyspnea', 'timeFrame': 'From inclusion until end of study', 'description': 'From each included patient, dyspnea scores will be collected from start of treatment until end of study or date of death (an expected average time frame of 10 years).'}, {'measure': 'Dysphagia', 'timeFrame': 'From treatment until end of study', 'description': 'Dysphagia scores will be collected from each participating patient from treatment until end of study or date of death (an average time frame of 10 years)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retrospective', 'Lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'A retrospective, data mining project that re-uses routine patient care data for decision support systems.', 'detailedDescription': 'By installing tools that extract clinical data from electronic health records and image data from the Picture Archiving and Communication System, decision support systems are built and validated that can predict survival and treatment toxicities of lung cancer patients treated with radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lung cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients notes as suffering from lung cancer in at least one clinical data source.'}, 'identificationModule': {'nctId': 'NCT01949259', 'briefTitle': 'Rapid Learning for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht Radiation Oncology'}, 'officialTitle': 'Rapid Learning in Practice: A Lung Cancer Survival Decision Support System in Routine Patient Care Data', 'orgStudyIdInfo': {'id': 'Rapid learning lung cancer'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective collection', 'description': 'Retrospective collection of data from included lung cancer patients.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 ET', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'MAASTRO clinic', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Andre Dekker, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastro Clinic, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht Radiation Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Liverpool Cancer Therapy Centre', 'class': 'OTHER_GOV'}, {'name': 'Macarthur Cancer Therapy Centre, Liverpool', 'class': 'OTHER'}, {'name': 'Ingham Institute Hospital, Liverpool', 'class': 'UNKNOWN'}, {'name': 'NSW, Australia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}