SARCOMAS: Integrated Clinical-radiological Analysis of Hypoxia Markers in Pediatric Osteosarcomas

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT05107843

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this pilot study is therefore to retrospectively measure the volume and percentage of necrosis on diagnostic MRI in T1 sequence and in parallel to study the expression of immunohistochemical markers of hypoxia (HIF-1α, CAIX , HIF-2α, pS6, phosphomTor, CD163 and CD68) on diagnostic biopsies of high-grade osteosarcomas from 2007 to 2018 in the Strasbourg center, focusing on the pediatric population. The investigators will systematically carry out a correlation analysis between these different parameters and with the clinical data of these same patients (response to chemotherapy, presence of metastases or not and overall and recurrence-free survival). This will eventually make it possible to highlight new prognostic markers at diagnosis.

Condition or Disease	Intervention/Treatment	Phase
Osteosarcoma in Children

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Integrated Clinical-radiological Analysis of Hypoxia Markers in Pediatric Osteosarcomas - Single-center Pilot Study of 32 Patients

Actual Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

Retropsective study of pediatric osteosarcomas [Files analysed retrospectively from January 01, 2007 to December 31, 2018 will be examined]]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 20 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Subject ≤ 20 years at diagnosis
Subject having been treated for osteosarcoma in the OS2006 protocol or treated according to
Supported at Strasbourg University Hospitals between 05/01/2007 and 10/31/2018
Availability of its diagnostic tumor material stored in paraffin
having an MRI diagnostic evaluation comprising the injected T1 sequences necessary for the analysis of the volume / necrotic proportion.

Exclusion Criteria:

Opposition of the patient (or his legal representatives if he is a minor) to participate in the study
Diagnosis other than osteosarcoma
Biological tissue from a patient who does not meet all the inclusion criteria
Patient under legal protection
Patient under guardianship or guardianship