Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma)OSENCT05071001
Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence
A study testing MRI in people with Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
To assess the neurocognitive outcomes in patients treated with chemotherapy for a malignant bone tumor during childhood and adolescence and the factors associated with neurocognitive impairment and/or complaints Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma)
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2021to 2 Jul 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For study OSE A and B
- Patients treated for a bone sarcoma: Ewing or osteosarcoma
- Age under 19 years at initial diagnosis
- Treated in the Pediatric Oncology Department of Gustave
- For patients diagnosed between 01.01.2001 and 31.12.2010: patients alive in complete remission at least 5 years after diagnosis
- Treated with at least one course of HDMTX for osteosarcoma
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- Treated without HDMTX for Ewing sarcoma
- Time interval between the end of treatment and inclusion >10 y
- Age > 21 y at inclusion
- Patients with informed consent signed
- Patient under guardianship
- Affiliated to French health insurance or beneficiary of the same or equivalent
- For study OSE- B only:
- Treated with at least 8 courses of HDMTX for osteosarcoma
- Treated without HDMTX for Ewing sarcoma
- Patients with Ewing sarcoma will have to be matched with osteosarcoma patients according to age at the time of treatment, sex, and duration of follow-up
- School level equivalent of at least the end of primary school
Who cannot join
- For study OSE A and B
- Brain radiotherapy
- Previous relapse except those treated by local treatment without any chemotherapy
- Second malignancy treated with chemotherapy
- High dose chemotherapy with stem cell support
- Non-French speaking patients
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- Pregnant and breastfeeding women
- For study OSE- B only:
- Patient deprived of his liberty by a judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
To assess the neurocognitive outcomes in patients treated with chemotherapy for a malignant bone tumor during childhood and adolescence and the factors associated with neurocognitive impairment and/or complaints
- Being tested
- MRI
- Medical subject headings
- Osteosarcoma, Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
This assessment will be planned in the year after the consent signAll patients will have one brain MRI performed in Henri Mondor Hospital on a 3T MR unit (Skyra, Siemens, Erlangen). The procedure will include:
- a 3D-FLAIR imaging
- a morphometric study based on a 3DT1 MPRAGE gradient echo sequence (TR / TI / TE = 2300/900 /2.9 ms)
- an analysis of the anatomic connectivity of the patient's brain assessed using a 1.5mm isotopic DTI with a high number of directions (HARDI / 65 directions / b=1500s/mm2).
- An evaluation of neuronal dysfunction using MR Spectroscopy. Spectroscopic data will be collected using a 2D CSI laser with a short TE technique.
- Magnetization transfer imaging providing information about integrity of membranes.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Procedure: MRI |
| B | Experimental | Not described Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
scores obtained in FactCOG as a whole and in each subscale
Primary analysis will be performed on all patients included in the study, including history of Ewing (treated without HDMTX) and osteosarcoma (treated with HDMTX). This population is the main analysis population of the study.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start19 Mar 2021
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma)Studies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071001
- Sponsor's protocol ID
- 2020-A00919-30
- Acronym
- OSE
- Status last verified
- Feb 2026
- First submitted
- 27 Sep 2021
- Last updated
- 5 Feb 2026
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence
- ClinicalTrials.gov ID
- NCT05071001
- Acronym / sponsor ID
- OSE / 2020-A00919-30
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 7 Oct 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.
To assess the neurocognitive outcomes in patients treated with chemotherapy for a malignant bone tumor during childhood and adolescence and the factors associated with neurocognitive impairment and/or complaints
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: MRI |
| B | Experimental | Procedure: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- For study OSE A and B
- Patients treated for a bone sarcoma: Ewing or osteosarcoma
- Age under 19 years at initial diagnosis
- Treated in the Pediatric Oncology Department of Gustave
- For patients diagnosed between 01.01.2001 and 31.12.2010: patients alive in complete remission at least 5 years after diagnosis
Key exclusion criteria (9 listed)
- For study OSE A and B
- Brain radiotherapy
- Previous relapse except those treated by local treatment without any chemotherapy
- Second malignancy treated with chemotherapy
- High dose chemotherapy with stem cell support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIThis assessment will be planned in the year after the consent signAll patients will have one brain MRI performed in Henri Mondor Hospital on a 3T MR unit (Skyra, Siemens, Erlangen). The procedure will include: 1. a 3D-FLAIR imaging 2. a morphometric study based on a 3DT1 MPRAGE gradient echo sequence (TR / TI / TE = 2300/900 /2.9 ms) 3. an analysis of the anatomic connectivity of the patient's brain assessed using a 1.5mm isotopic DTI with a high number of directions (HARDI / 65 directions / b=1500s/mm2). 4. An evaluation of neuronal dysfunction using MR Spectroscopy. Spectroscopic data will be collected using a 2D CSI laser with a short TE technique. 5. Magnetization transfer imaging providing information about integrity of membranes. | Procedure or surgery | A, B |
Primary outcome
scores obtained in FactCOG as a whole and in each subscale
Time frame: 3 years
Primary analysis will be performed on all patients included in the study, including history of Ewing (treated without HDMTX) and osteosarcoma (treated with HDMTX). This population is the main analysis population of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma), run by Gustave Roussy, Cancer Campus, Grand Paris 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 17 inclusion and 9 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: finished, as of the sponsor's last update on 5 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scores obtained in FactCOG as a whole and in each subscale (time frame: 3 years). 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 5 Feb 2026.