Integrated Clinical-radiological Analysis of Hypoxia Markers in Pediatric Osteosarcomas

Osteosarcoma in Children Clinical Trial

— SARCOMAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05107843
• Other study ID #: 7715
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Strasbourg, France
• Contact: Natacha ENTZ-WERLE, MD, PhD
• Phone: 33.3.88.12.80.96
• Email: Natacha.Entz-Werle[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 1 Year to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Osteosarcoma
• Osteosarcoma in Children

Locations

Country	Name	City	State
France	Service Pédiatrie Onco-hématologie - Pédiatrie III - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retropsective study of pediatric osteosarcomas		Files analysed retrospectively from January 01, 2007 to December 31, 2018 will be examined]