OOSLOH: Regional Database for Collecting Clinical-biological and Imaging Data "Secondary Bone Oncology and Bone Localizations of Hematologic Diseases"

Sponsor
University Hospital, Lille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05495802
Collaborator
Lille University Hospital Emergence Fund (Other)
5,000
120

Study Details

Study Description

Brief Summary

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.

Some 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.

To 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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Regional Database for Collecting Clinical-biological and Imaging Data "Secondary Bone Oncology and Bone Localizations of Hematologic Diseases"
    Anticipated Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Nov 1, 2032
    Anticipated Study Completion Date :
    Dec 1, 2032

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of alive patients [through study completion, an average of 10 years]

    Secondary Outcome Measures

    1. Percentage of patients without bone disease recurrence [within one year after the multidisciplinary meeting]

    2. Time to bone disease recurrence [through study completion, an average of 10 years]

    3. Number of bone recurrence Number of bone recurrence [At each presentation of the patient file's to the MM,on average every week]

    4. Epidemiological datas [At the first presentation of patient's file to the MM, on average every week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient aged 18 or over,

    • 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

    • Social insured patient

    Exclusion Criteria:
    • Patient who died before presentation to OOSLOH MM,

    • Minor patient,

    • Patient objecting to the use of their data for research purposes,

    • Patient unable to express his right to object to his participation in the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Lille
    • Lille University Hospital Emergence Fund

    Investigators

    • Principal Investigator: Marie-Hélène VIEILLARD, MD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT05495802
    Other Study ID Numbers:
    • 2019_59
    • 2021-A00829-32
    First Posted:
    Aug 10, 2022
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 10, 2022