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NCT Number: NCT06924463

Identification of Specific Molecular Signatures in Pediatric, Adolescent, and Young Adult Rhabdomyosarcoma Through Spatial Proteome Analysis Using Mass Spectrometry

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.

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Key information

Conditions

Rhabdomyosarcoma Myosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Sarcoma

Age range

0 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oscar Lambret Center

Lille, Nord, 59000, France

Location status: Recruiting

Location contact

François Sévrin, MD

CONTACT

[email protected]

+33650329725

François Sévrin, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Unavailability of biological sample in FFPE from biopsy and/or surgical specimen for diagnosis at Centre Oscar Lambret;
  • Patient under guardianship or trusteeship.

Treatment and study plan

None AHT

Other

This study does not involve any interventions. It analyzes pre-existing biological samples (FFPE tumor tissue) and clinical data from patients with rhabdomyosarcoma.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Lille University

Other

Collaborators

  • Centre Oscar Lambret, Lille, France

Registry information

Official study 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

Acronym: AERO-RMS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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