Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT05495802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-08-10
First Post:
2021-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regional Database for Collecting Clinical-biological and Imaging Data "Secondary Bone Oncology and Bone Localizations of Hematologic Diseases"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2022-08-08', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of alive patients', 'timeFrame': 'through study completion, an average of 10 years'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients without bone disease recurrence', 'timeFrame': 'within one year after the multidisciplinary meeting'}, {'measure': 'Time to bone disease recurrence', 'timeFrame': 'through study completion, an average of 10 years'}, {'measure': 'Number of bone recurrence Number of bone recurrence', 'timeFrame': "At each presentation of the patient file's to the MM,on average every week"}, {'measure': 'Epidemiological datas', 'timeFrame': "At the first presentation of patient's file to the MM, on average every week"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone localisations of haematological diseases', 'Cancer', 'bone metastasis', 'haematological diseases', 'quality of life', 'epidemiological data'], 'conditions': ['Bone Metastases']}, 'descriptionModule': {'briefSummary': 'Improving the effectiveness of cancer treatments makes it possible to lengthen patient survival. It is therefore important to ensure that the quality of life is also maintained by reducing pain and handicap.\n\nSome cancers tend to spread to the bone. The bone locations of cancer can weaken the bone and lead to complications such as fractures, pain, or compression of neurological structures.\n\nTo avoid such complications, weekly multidisciplinary meetings (MM) bring together specialists (oncologists, rheumatologists, cancer surgeons, radiologists, radiotherapists, etc.) to discuss the files of patients with bone lesions from cancer. They offer specific treatments adapted to each patient to treat or reduce the risk of complications. The OOSLOH study aims to collect clinical, biological, and imaging data from patients for whom a discussion took place in bone dedicated MM. Based on these data, epidemiological studies could be carried out to better understand the clinical factors leading cancer to colonize bone. But also to determine the factors making it possible to prevent or better treat bone complications and improve the quality of life of patients. This study does not require any examinations or additional visits to the patient'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients whose file is presented in MM OOSLOH for a diagnostic, therapeutic or follow-up question of a malignant bone lesion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 18 or over,\n* Patient whose file is presented to the OOSLOH MM and who has not objected to the use of his non-nominative clinical, biological and imaging data\n* Social insured patient\n\nExclusion Criteria:\n\n* Patient who died before presentation to OOSLOH MM,\n* Minor patient,\n* Patient objecting to the use of their data for research purposes,\n* Patient unable to express his right to object to his participation in the study.'}, 'identificationModule': {'nctId': 'NCT05495802', 'acronym': 'OOSLOH', 'briefTitle': 'Regional Database for Collecting Clinical-biological and Imaging Data "Secondary Bone Oncology and Bone Localizations of Hematologic Diseases"', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Regional Database for Collecting Clinical-biological and Imaging Data "Secondary Bone Oncology and Bone Localizations of Hematologic Diseases"', 'orgStudyIdInfo': {'id': '2019_59'}, 'secondaryIdInfos': [{'id': '2021-A00829-32', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marie-Hélène VIELLARD, MD', 'role': 'CONTACT', 'email': 'Marie-Helene.VIEILLARD@chu-lille.fr', 'phone': '0320445962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Marie-Hélène VIEILLARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lille University Hospital Emergence Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}