Integrated Clinical-radiological Analysis of Hypoxia Markers in Pediatric Osteosarcomas

NCT05107843 | Unknown

• 1 other identifier: 7715
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteosarcoma in Children

Keywords

Osteosarcoma; Necrosis; Immunohistochemical markers of hypoxia; Hypoxia; Chemotherapy; Metastasis

Outcome Measures

Primary Outcomes (1)

• Retropsective study of pediatric osteosarcomas

  Files analysed retrospectively from January 01, 2007 to December 31, 2018 will be examined]

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subject ≤ 20 years having been treated for osteosarcoma in the OS2006 protocol or treated according to.

You may qualify if:

• 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.

You may not qualify if:

• Opposition of the patient (or his legal representatives if he is a minor) to participate in the study
• Diagnosis other than osteosarcoma
• Patient under legal protection
• Patient under guardianship or guardianship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service Pédiatrie Onco-hématologie - Pédiatrie III - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Osteosarcoma; Necrosis; Hypoxia; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Neoplastic Processes

Study Officials

• Natacha ENTZ-WERLE, MD, PhD

  Service Pédiatrie Onco-hématologie - Pédiatrie III - Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natacha ENTZ-WERLE, MD, PhD

CONTACT

33.3.88.12.80.96; Natacha.Entz-Werle@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

said.chayer@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 4, 2021
• Study Start: February 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

FR (1)