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OSTEO LR: An Observational Study of Local Relapse After High Grade Osteosarcoma

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Recruiting
CT.gov ID
NCT06017518
Collaborator
(none)
150
Enrollment
2
Locations
48.6
Anticipated Duration (Months)
75
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

multicenter retrospective and prospective study in patients with high-grade osteosarcoma

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a multicenter retrospective and prospective study that will analyze all cases with of diagnosis of local relapse in high-grade osteosarcoma from 01 January 1980 and all new cases referring to each participant site.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    An Observational Study of Local Relapse After High Grade Osteosarcoma
    Actual Study Start Date :
    Jun 13, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2026
    Anticipated Study Completion Date :
    Jun 30, 2026

    Outcome Measures

    Primary Outcome Measures

    1. post local relapse survival [24 months follow up]

      the aim of the study is to analyse the factors influencing post local relapse survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who experienced LR as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases

    • Adequate patient compliance to follow-up visits

    • Written informed consent prior to any study-specific analysis and/or data collection

    • No age limits

    Exclusion Criteria:

    • Cases of LR demonstrated after > 3 months after metastatic disease

    • Impossibility to ensure adequate compliance

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Istituto Ortopedico Rizzoli Bologna BO Italy 40136
    2 Azienda Ospedaliero-Universitaria Pisana Pisa PI Italy 56126

    Sponsors and Collaborators

    • Istituto Ortopedico Rizzoli

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Ortopedico Rizzoli
    ClinicalTrials.gov Identifier:
    NCT06017518
    Other Study ID Numbers:
    • OSTEO LR
    First Posted:
    Aug 30, 2023
    Last Update Posted:
    Aug 30, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteosarcoma

    Study Results

    No Results Posted as of Aug 30, 2023