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

October 25, 2021 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service Pédiatrie Onco-hématologie - Pédiatrie III - Hôpitaux Universitaires de Strasbourg
        • Principal Investigator:
          • Natacha ENTZ-WERLE, MD, PhD
        • Sub-Investigator:
          • François SEVERAC, MD
        • Contact:
        • Sub-Investigator:
          • Charlotte NAZON, MD
        • Sub-Investigator:
          • Thibault WILLAUME, MD
        • Sub-Investigator:
          • Benoit LHERMITTE, MD
        • Sub-Investigator:
          • Marina PIERREVELCIN, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 20 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retropsective study of pediatric osteosarcomas
Time Frame: Files analysed retrospectively from January 01, 2007 to December 31, 2018 will be examined]
Files analysed retrospectively from January 01, 2007 to December 31, 2018 will be examined]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Natacha ENTZ-WERLE, MD, PhD, Service Pédiatrie Onco-hématologie - Pédiatrie III - Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7715

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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