Diagnostic and Therapeutic Targets in Cartilaginous Tumours

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSt. Anne's University Hospital Brno, Czech Republic

About this trial

This study, "Finding new diagnostic and therapeutic targets in cartilaginous tumours," focuses on improving the diagnosis, prognostic stratification, and treatment options for chondroid tumours, particularly chondrosarcoma. Chondrosarcoma is the most common primary malignant bone tumour in adults and is characterized by resistance to chemotherapy and radiotherapy, making accurate diagnosis and optimal surgical management critical. Distinguishing benign cartilage tumours (enchondromas, atypical cartilaginous tumours) from low-grade chondrosarcoma, and differentiating chondrosarcoma from chondroblastic osteosarcoma, remain major diagnostic challenges.

The project investigates two key molecular markers: mutations in IDH1/2 genes and non-coding microRNAs (miRNAs). IDH1/2 mutations are frequent in central chondrosarcomas and rare in other mesenchymal tumours, making them promising diagnostic markers. Their presence may also have prognostic significance and therapeutic relevance, as IDH inhibitors are already available for other malignancies. In parallel, deregulated miRNA expression has been implicated in chondrosarcoma biology, influencing tumour growth, invasion, angiogenesis, metastasis, and chemosensitivity. Preliminary data identified distinct miRNA signatures in chondrosarcoma compared with healthy cartilage, including previously unreported miRNAs.

The study is structured into exploratory and validation phases. Global miRNA expression profiling and IDH1/2 mutation analysis will be performed using next-generation sequencing (NGS) on prospectively collected fresh-frozen tumour samples. Selected miRNAs and IDH1/2 mutation status will then be validated by RT-qPCR and targeted mutation assays in a large retrospective cohort of FFPE samples. Molecular data will be integrated with clinicopathological parameters to develop diagnostic panels capable of accurately classifying chondroid tumours, as well as prognostic miRNA panels associated with patient survival.

Additionally, the project evaluates circulating and exosomal miRNAs in liquid biopsies, aiming to establish non-invasive diagnostic and prognostic tools. Functional relevance will be explored using chondrosarcoma cell lines with simulated miRNA upregulation, coupled with transcriptomic analysis.

Overall, the study seeks to refine diagnostic accuracy, improve prognostic assessment, and identify novel molecular targets for personalized and targeted therapy in patients with inoperable or metastatic chondrosarcoma, addressing a major unmet clinical need.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed cartilaginous (chondroid) tumour

Enchondroma

Atypical cartilaginous tumour / Grade 1 chondrosarcoma (ACT/G1)

Conventional chondrosarcoma (Grade 2-3)

Disqualifiers

Insufficient, degraded, or otherwise unusable tissue samples

Trial population

The study population will consist of patients with cartilaginous (chondroid) tumours treated at the First Department of Orthopaedic Surgery, St. Anne's University Hospital Brno, a national referral centre for bone tumours.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tumour tissue analysis

    Diagnostic test

    Next-generation sequencing (NGS) to determine IDH1/2 mutation status Global microRNA (miRNA) expression profiling using NGS

  • Molecular validation

    Diagnostic test

    Quantitative reverse transcription PCR (RT-qPCR) to validate selected miRNAs Targeted molecular assays for confirmation of IDH1/2 mutations

  • Liquid biopsy analysis

    Diagnostic test

    Assessment of circulating and exosomal miRNAs from patient body fluids as non-invasive biomarkers

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Patients with cartilaginous bone tumours3 interventions

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of molecular markers

Ability of IDH1/2 mutation status and tumour tissue miRNA expression profiles to: Distinguish benign cartilaginous tumours (enchondromas, atypical cartilaginous tumours) from malignant tumours (chondrosarcomas). Distinguish chondrosarcoma from chondroblastic osteosarcoma. Outcomes will be quantified using molecular classification performance (e.g. correct stratification against histopathological diagnosis) based on NGS and RT-qPCR analyses.

Time frame
From May 2025 to December 2027
2

Identification of prognostic molecular signatures

Association between IDH1/2 mutation status and overall survival of patients with malignant cartilaginous tumours. Identification of prognostic miRNA panels whose expression profiles stratify patients into different survival risk groups.

Time frame
From May 2025 to December 2027

Secondary outcomes

1

Validation of candidate biomarkers

Technical and biological validation of selected deregulated miRNAs and IDH1/2 mutations in an independent retrospective FFPE cohort using RT-qPCR and targeted mutation assays. Reproducibility and stability of miRNA panels across different sample types (fresh-frozen vs FFPE tissue).

Time frame
From May 2025 to December 2027
2

Liquid biopsy feasibility

Detection and quantification of circulating and exosomal miRNAs in prospectively collected body fluids. Concordance between miRNA profiles in liquid biopsies and matched tumour tissue samples.

Time frame
From May 2025 to December 2027

Other outcomes

Sponsors and contacts

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