Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-31 @ 9:10 PM
Study NCT ID:
NCT05069792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-24', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Health-related Quality of Life', 'timeFrame': 'Up to 10 years after treatment', 'description': 'Assesment of Health-related quality of life in lung cancer patients undergoing treatment'}, {'measure': 'Occurence of toxicity (adverse events)', 'timeFrame': 'Up to 10 years after treatment', 'description': "Grade ≥3 side effects occurring during or up to 3 months after radiotherapy will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). For 'dysphagia' and 'pneumonitis' endpoints, also grade 2 toxicity will be scored."}, {'measure': 'Readmission', 'timeFrame': 'Up to 10 years after treatment', 'description': 'Reintervention (re-irradiation, surgery, other), tube feeding requirement or treatment for local and/or distant progression.'}, {'measure': 'Survival', 'timeFrame': 'Up to 10 years after treatment', 'description': 'Date of last follow-up, date of local progression, date of distant progression, location of distant progression. Overall survival (Survival of participating patients will be recorded using the follow up questionnaires \\[returned by family members\\] or are derived from the Statistic Netherlands Database \\[in Dutch: Centraal Bureau voor de Statistiek, CBS\\] and Dutch Cancer Registry \\[in Dutch: Integraal Kankercentrum Nederland, IKNL\\]).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': "Objective: 1) To collect information on patient characteristics, short- and long-term clinical and patient-reported outcomes; and 2) to create an infrastructure for efficient, fast, and pragmatic randomized evaluation of new interventions.\n\nStudy design: Observational, prospective cohort study, according to the 'TwiCs' design.\n\nStudy population: All patients with lung cancer referred to the Department of Pulmonology or the Department of Radiotherapy of the UMC Utrecht.\n\nMain study parameters/endpoints: Clinical parameters (performance status, co-morbidity, oncological history, symptoms, imaging, technical and treatment data), clinical endpoints (toxicity, reintervention and survival), and patient-reported outcomes.", 'detailedDescription': 'The prospective U-COLOR cohort (Utrecht COhort for Lung cancer Outcome Reporting and trial inclusion), aims to:\n\n* Gather data on natural disease progression, treatment response, disease recurrence, complications, quality of life and survival of patients with lung cancer;\n* Collect a patient group willing to participate in studies;\n* Facilitate multiple, parallel randomized controlled trials within the cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who are referred to the Department of Pulmonology or the Department of Radiotherapy of the UMC Utrecht for treatment of lung cancer will be eligible to be enrolled in the U-COLOR cohort.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Radiographic and/or histologic proof of lung cancer;\n* Referred to Department of Pulmonology or the Department of Radiotherapy for treatment.\n\nExclusion Criteria:\n\n* Mental disorder or cognitive dysfunction that hinders the patient's ability to understand the informed consent procedure and/or study details;\n* Patients with severe psychiatric disorders;\n* Inability to understand the Dutch language."}, 'identificationModule': {'nctId': 'NCT05069792', 'acronym': 'U-COLOR', 'briefTitle': 'Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)', 'orgStudyIdInfo': {'id': 'NL71047.041.19'}}, 'contactsLocationsModule': {'locations': [{'zip': '3508GA', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Helena M Verkooijen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Helena M Verkooijen', 'investigatorAffiliation': 'UMC Utrecht'}}}}