Clinical Applicability of Liquid Biopsy in Chondrosarcoma

March 19, 2026 updated by: Medical University of Graz

Clinical Applicability of Liquid Biopsy in Intermediate and Malignant Cartilaginous Neoplasms - A Prospective Cohort Study

Treatment of intermediate (i.e. atypical cartilaginous tumour, ACT) and malignant cartilaginous tumours (i.e. chondrosarcoma) involves surgical resection, while effects of systemic therapies are limited. Thus, it is of importance to diagnose these tumours timely, estimate their prognosis, and detect recurrences at early stages. Apart from diagnosis and disease monitoring with cost-intensive, as well as ionizing radiation-exposing imaging modalities, liquid biopsy constitutes a potent, non-invasive diagnostic, prognostic and predictive tool in oncology. Intermediate/malignant cartilaginous neoplasms are known to frequently harbour specific mutations, as Isocitrate dehydrogenase 1/2 (IDH1/2). These may well be detectable with liquid biopsy, a non-invasive diagnostic measure. Further, other genetic alterations found in primary tumour tissue as well as cytokines/chemokines may be of additive diagnostic and prognostic value.

This prospective cohort study aims at answering 4 questions: 1) Possibility to differentiate between ACT and higher-grade chondrosarcoma by measuring mutant IDH1/2 circulating free DNA (cfDNA) in blood stream; 2) Feasibility to detect recurrences during follow-up by monitoring mutant IDH1/2 cfDNA; 3) Prognostic potential of high mutant IDH1/2 cfDNA levels; 4) Additive diagnostic/prognostic value of other genetic alterations found in primary tumour tissue as well as cytokine profiling.

Over 2 years, an estimated 60 patients with intermediate/malignant cartilaginous tumours will meet the inclusion criteria. At 11 time points (preoperatively, postoperatively, after 6 weeks, as well as 3, 6, 9, 12, 15, 18, 21 and 24 months), blood samples will be ascertained. The following methodological steps will be carried out: 1) next generation sequencing of primary tumour tissue towards IDH1/2 mutations (and further genetic alterations); 2) selection of digital droplet polymerase chain reaction (ddPCR) assays with patient-specific probes; 3) blood sample collection; 4) cfDNA extraction from blood samples; 5) Quantification of mutant IDH1/2 cfDNA with ddPCR; 6) cytokine and chemokine profiling in blood samples. Patients will be followed-up for 2 years, resulting in an overall study period of 4 years.

This study may help to elucidate the role of liquid biopsy in diagnosis and follow-up of patients with chondrosarcoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Department of Orthopaedics and Trauma
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (age 18 - 99 years) diagnosed with semimalignant (atypical cartilaginous tumour) or malignant (chondrosarcoma G1/2/3, dedifferentiated chondrosarcoma) cartilaginous neoplasm undergoing surgery at a single tertiary sarcoma centre.

Description

Inclusion Criteria:

  • Semimalignant or malignant cartilaginous tumour (atypical cartilaginous tumour, chondrosarcoma G1/2/3, dedifferentiated chondrosarcoma)
  • Definite surgery of primary tumour

Exclusion Criteria:

  • Prior tumour-specific treatment (except for biopsy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient cohort
Patients diagnosed with atypical cartilaginous tumours or chondrosarcomas undergoing surgery.
Diagnostic test: laboratory biomarker analysis
Laboratory biomarker analysis at several pre-defined time points during follow-up.
Other: Molecular pathology
Testing of primary tumour tissue with next generation sequencing towards presence of IDH and other mutations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NGS analysis of primary tumour tissue
Time Frame: Up to 12 weeks following biopsy/definite surgery
Analysis of primary tumour tissue with next generation sequencing for presence of IDH and other mutations
Up to 12 weeks following biopsy/definite surgery
Digital droplet PCR
Time Frame: From 1 week prior to biopsy/surgery up to 24 months after biopsy/surgery (or in case of development of recurrent disease, up to 24 months following recurrence).
Analyse blood samples obtained ad pre-defined time points during follow-up with digital droplet PCR towards presence of patient-specific mutations.
From 1 week prior to biopsy/surgery up to 24 months after biopsy/surgery (or in case of development of recurrent disease, up to 24 months following recurrence).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune profiling
Time Frame: From 1 week prior to biopsy/surgery up to 24 months after biopsy/surgery (or in case of development of recurrent disease, up to 24 months following recurrence).
Carry out immune profiling (i.e. next generation sequencing [NGS]-based proteomics of cytokines/chemokines) using blood samples obtained ad pre-defined time points during follow-up.
From 1 week prior to biopsy/surgery up to 24 months after biopsy/surgery (or in case of development of recurrent disease, up to 24 months following recurrence).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

May 31, 2030

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35-361 ex 22/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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