RhabdomyosarcomaAERO-RMSNCT06924463
Identification of Specific Molecular Signatures in Pediatric, Adolescent, and Young Adult Rhabdomyosarcoma Through Spatial Proteome Analysis Using Mass Spectrometry
An observational study of Rhabdomyosarcoma, run by Lille University at 1 site in France.
Trial summary
This non-interventional study aims to develop spatial proteomics for analyzing small FFPE tumor samples in rhabdomyosarcoma. It will identify molecular signatures linked to tumor regions, subtypes, survival, and treatment resistance, using pre-existing samples and data. Read more about this study
- Who is it for?
- Ages 0 to 25 years
- Conditions the study is for
- Rhabdomyosarcoma
- What is being tested?
- None AHT
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Oscar Lambret Center (Lille, France)
Who may be able to join
- Age between 0 and 25 years at the time of initial diagnosis
- Diagnosis of rhabdomyosarcoma confirmed histologically
- Care at the Oscar Lambret Center between January 2005 and November 2024
- No objection to the re-use of data and biological samples collected as part of care for research activities.
Who cannot join
- Unavailability of biological sample in FFPE from biopsy and/or surgical specimen for diagnosis at Centre Oscar Lambret;
- Patient under guardianship or trusteeship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Oscar Lambret Center
Lille, Nord, 59000
François Sévrin, MD, +33650329725, f-sevrin@o-lambret.fr
François Sévrin, MD
About this study
Official title: Identification de Signatures moléculaires spécifiques Dans le Rhabdomyosarcome de l'Enfant, de l'Adolescent et du Jeune Adulte, Par Analyse Spatiale du protéome Par spectrométrie de Masse
This non-interventional study aims to develop spatial proteomics for analyzing small FFPE tumor samples in rhabdomyosarcoma. It will identify molecular signatures linked to tumor regions, subtypes, survival, and treatment resistance, using pre-existing samples and data.
Read the detailed description
This is a non-interventional, monocentric, retrospective cohort study aimed at developing a spatial proteomics analysis method for small tumor samples (FFPE) to precisely characterize proteins at the tissue level in rhabdomyosarcoma (RMS). Using mass spectrometry, the study will identify molecular signatures associated with different tumor regions, histological subtypes, patient survival, and treatment resistance. The goal is to identify potential protein biomarkers and therapeutic targets. Data from clinical samples will be analyzed to find biomarkers correlated with survival and resistance to treatment. No patient intervention is required, as the study uses pre-existing biological samples and clinical data.
- Conditions
- Rhabdomyosarcoma
- Being tested
- None AHT
- Keywords
- rhabdomyosarcoma, molecular signatures, spatial proteome, targeted therapy
- Medical subject headings
- Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None AHTOther
This study does not involve any interventions. It analyzes pre-existing biological samples (FFPE tumor tissue) and clinical data from patients with rhabdomyosarcoma.
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial Proteomic Profiling of Tumor Samples
Evaluate the ability to obtain distinct proteomic profiles from at least 75% of tumor samples analyzed, with a minimum of two distinct profiles identified per sample.
Measured: 12 months (study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start13 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyosarcomaStudies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Oscar Lambret, Lille, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924463
- Sponsor's protocol ID
- D2024-7
- Acronym
- AERO-RMS
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification de Signatures moléculaires spécifiques Dans le Rhabdomyosarcome de l'Enfant, de l'Adolescent et du Jeune Adulte, Par Analyse Spatiale du protéome Par spectrométrie de Masse
- ClinicalTrials.gov ID
- NCT06924463
- Acronym / sponsor ID
- AERO-RMS / D2024-7
- Conditions
- Rhabdomyosarcoma
- Keywords
- rhabdomyosarcoma, molecular signatures, spatial proteome, targeted therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lille UniversityUniversity, hospital or other
- Collaborators
- Centre Oscar Lambret, Lille, France
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 11 Apr 2025 (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.
This non-interventional study aims to develop spatial proteomics for analyzing small FFPE tumor samples in rhabdomyosarcoma. It will identify molecular signatures linked to tumor regions, subtypes, survival, and treatment resistance, using pre-existing samples and data.
Detailed description
This is a non-interventional, monocentric, retrospective cohort study aimed at developing a spatial proteomics analysis method for small tumor samples (FFPE) to precisely characterize proteins at the tissue level in rhabdomyosarcoma (RMS). Using mass spectrometry, the study will identify molecular signatures associated with different tumor regions, histological subtypes, patient survival, and treatment resistance. The goal is to identify potential protein biomarkers and therapeutic targets. Data from clinical samples will be analyzed to find biomarkers correlated with survival and resistance to treatment. No patient intervention is required, as the study uses pre-existing biological samples and clinical data.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Oscar Lambret Center (Lille, France)
Key inclusion criteria (4 listed)
- Age between 0 and 25 years at the time of initial diagnosis
- Diagnosis of rhabdomyosarcoma confirmed histologically
- Care at the Oscar Lambret Center between January 2005 and November 2024
- No objection to the re-use of data and biological samples collected as part of care for research activities.
Key exclusion criteria (2 listed)
- Unavailability of biological sample in FFPE from biopsy and/or surgical specimen for diagnosis at Centre Oscar Lambret;
- Patient under guardianship or trusteeship.
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 |
|---|---|---|
| None AHTThis study does not involve any interventions. It analyzes pre-existing biological samples (FFPE tumor tissue) and clinical data from patients with rhabdomyosarcoma. | Other | – |
Primary outcome
Spatial Proteomic Profiling of Tumor Samples
Time frame: 12 months (study duration)
Evaluate the ability to obtain distinct proteomic profiles from at least 75% of tumor samples analyzed, with a minimum of two distinct profiles identified per sample.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 Rhabdomyosarcoma, run by Lille University 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 11 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial Proteomic Profiling of Tumor Samples (time frame: 12 months (study duration)). 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 11 Apr 2025.