Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-01-17 @ 2:10 AM
Study NCT ID:
NCT03840720
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2019-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Patient's Journey - the Time to Final Diagnosis in Patients With SiNET
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-27', 'studyFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2019-02-12', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial symptoms', 'timeFrame': 'October 2019', 'description': 'Mapping of patients initial symptoms and their time points through indepths interviews by design thinking methodology'}, {'measure': 'Health care actions', 'timeFrame': 'October 2019', 'description': 'Mapping of corresponding health care actions and their time points regarding the investigations of symptoms'}, {'measure': 'Reasons for a delayed diagnosis', 'timeFrame': 'October 2019', 'description': 'Mapping of herdles and delays in reaching a final diagnosis through design thinking methodology analysing the patients symptoms and the corresponding Health care actions'}], 'secondaryOutcomes': [{'measure': "Patients' efforts", 'timeFrame': 'October 2019', 'description': 'Mapping of actions taken by the patient, trying to be diagnosed correctly, through indepths interviews by design thinking methodology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroendocrine Tumors']}, 'descriptionModule': {'briefSummary': '"The patient\'s journey" is an interview based study assessing the patients\' experience from the first symptoms to a final diagnosis focusing on patients with small intestinal neuroendocrine tumors.', 'detailedDescription': 'The project focus on patients with small intestinal neuroendocrine tumors (SiNET\'s) with an incidence of 1-2/100 000 yearly. The primary tumor(s) are often small and symptoms usually arise when the disease has become metastatic with hormonal symptoms and/or symptoms due to local growth. As the tumors grow slowly and the symptoms in many cases are rather diffuse and develops gradually over a long time period there is often a long delay from onset to a final diagnosis both depending on "patient\'s delay" and "doctor\'s delay" The aim of the current project is to map and analyze the patient\'s journey from the first appearance of symptoms to the time point of a final diagnosis and to try to identify factors contributing to a delayed process.\n\nThe method is interview based and the interviews will be analyzed through the Design Thinking Methodology'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in Western Sweden, \\> 18 years of age that has been diagnosed with a small intestinal neuroendocrine tumor during 2016-2018', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients living in Western Sweden\n* \\> 18 years of age\n* Performance status 0-3\n* Expected remaining survival of \\> 6 months\n* Diagnosed with a small intestinal neuroendocrine tumor during 2016-2018\n\nExclusion Criteria:\n\n* Not able to read and/or understand Swedish language\n* Dementia/memory loss\n* Performance status \\>3'}, 'identificationModule': {'nctId': 'NCT03840720', 'briefTitle': "The Patient's Journey - the Time to Final Diagnosis in Patients With SiNET", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': "The Patient's Journey - Assessing the Time to Final Diagnosis in Patients With Neuroendocrine Tumors (NET) in Western Sweden", 'orgStudyIdInfo': {'id': 'PR-1.0'}}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Dept of Oncology', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Andreas Hallqvist, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Andreas Hallqvist', 'investigatorAffiliation': 'Vastra Gotaland Region'}}}}