Osteosarcoma in ChildrenSARCOMASNCT05107843
Integrated Clinical-radiological Analysis of Hypoxia Markers in Pediatric Osteosarcomas
An observational study of Osteosarcoma in Children, run by University Hospital, Strasbourg, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- Osteosarcoma in Children
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 20 years
- All sexes
- Child, Adult
Study population: Subject ≤ 20 years having been treated for osteosarcoma in the OS2006 protocol or treated according to.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service Pédiatrie Onco-hématologie - Pédiatrie III - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Natacha ENTZ-WERLE, MD, PhD, 33 3 88 12 80 96, Natacha.Entz-Werle@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: 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.
- Conditions
- Osteosarcoma in Children
- Keywords
- Osteosarcoma, Necrosis, Immunohistochemical markers of hypoxia, Hypoxia, Chemotherapy, Metastasis
- Medical subject headings
- Osteosarcoma, Necrosis, Hypoxia, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retropsective study of pediatric osteosarcomas
Measured: Files analysed retrospectively from January 01, 2007 to December 31, 2018 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Feb 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteosarcoma in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natacha ENTZ-WERLE, MD, PhD, Principal investigator, Service Pédiatrie Onco-hématologie - Pédiatrie III - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107843
- Sponsor's protocol ID
- 7715
- Acronym
- SARCOMAS
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Clinical-radiological Analysis of Hypoxia Markers in Pediatric Osteosarcomas - Single-center Pilot Study of 32 Patients
- ClinicalTrials.gov ID
- NCT05107843
- Acronym / sponsor ID
- SARCOMAS / 7715
- Conditions
- Osteosarcoma in Children
- Keywords
- Osteosarcoma, Necrosis, Immunohistochemical markers of hypoxia, Hypoxia, Chemotherapy, Metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Subject ≤ 20 years having been treated for osteosarcoma in the OS2006 protocol or treated according to.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retropsective study of pediatric osteosarcomas
Time frame: Files analysed retrospectively from January 01, 2007 to December 31, 2018 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saïd CHAYER, PhD, HDR contact
Natacha ENTZ-WERLE, MD, PhD principal investigator
Service Pédiatrie Onco-hématologie - Pédiatrie III - Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma in Children, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natacha ENTZ-WERLE, MD, PhD (33.3.88.12.80.96, Natacha.Entz-Werle@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retropsective study of pediatric osteosarcomas (time frame: Files analysed retrospectively from January 01, 2007 to December 31, 2018 will be examined]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.