Chondrosarcoma of the BoneNCT07492823
Clinical Applicability of Liquid Biopsy in Chondrosarcoma
An observational study of Chondrosarcoma of the Bone, run by Medical University of Graz at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chondrosarcoma of the Bone
- What is being tested?
- laboratory biomarker analysis and Molecular pathology
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2026to 31 May 2030
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Semimalignant or malignant cartilaginous tumour (atypical cartilaginous tumour, chondrosarcoma G1/2/3, dedifferentiated chondrosarcoma)
- Definite surgery of primary tumour
Who cannot join
- Prior tumour-specific treatment (except for biopsy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Orthopaedics and Trauma
Graz, Styria, 8036
Maria Anna Smolle, MD, 0043 316 385 81881, maria.smolle@medunigraz.at
About this study
Official title: 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.
Read more
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.
- Conditions
- Chondrosarcoma of the Bone
- Being tested
- laboratory biomarker analysis, Molecular pathology
- Keywords
- chondrosarcoma, liquid biopsy, chemokine profiling, atypical cartilaginous tumour
- Medical subject headings
- Chondrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisDiagnostic test
Laboratory biomarker analysis at several pre-defined time points during follow-up.
Molecular pathologyOther
Testing of primary tumour tissue with next generation sequencing towards presence of IDH and other mutations.
| Study group | Role | What they receive |
|---|---|---|
| Patient cohort | Patients diagnosed with atypical cartilaginous tumours or chondrosarcomas undergoing surgery. Receives: Diagnostic Test: laboratory biomarker analysis; Other: Molecular pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
NGS analysis of primary tumour tissue
Analysis of primary tumour tissue with next generation sequencing for presence of IDH and other mutations
Measured: Up to 12 weeks following biopsy/definite surgery
Digital droplet PCR
Analyse blood samples obtained ad pre-defined time points during follow-up with digital droplet PCR towards presence of patient-specific mutations.
Measured: 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 outcomes (1)
Immune profiling
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Jun 2026
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chondrosarcoma of the BoneStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492823
- Sponsor's protocol ID
- 35-361 ex 22/23
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 7 Oct 2026
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applicability of Liquid Biopsy in Intermediate and Malignant Cartilaginous Neoplasms - A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07492823
- Acronym / sponsor ID
- 35-361 ex 22/23
- Conditions
- Chondrosarcoma of the Bone
- Keywords
- chondrosarcoma, liquid biopsy, chemokine profiling, atypical cartilaginous tumour
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 25 Mar 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient cohort | – | Diagnostic Test: laboratory biomarker analysis, Other: Molecular pathologyPatients diagnosed with atypical cartilaginous tumours or chondrosarcomas undergoing surgery. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Semimalignant or malignant cartilaginous tumour (atypical cartilaginous tumour, chondrosarcoma G1/2/3, dedifferentiated chondrosarcoma)
- Definite surgery of primary tumour
Key exclusion criteria (1 listed)
- Prior tumour-specific treatment (except for biopsy)
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 |
|---|---|---|
| laboratory biomarker analysisLaboratory biomarker analysis at several pre-defined time points during follow-up. | Diagnostic test | Patient cohort |
| Molecular pathologyTesting of primary tumour tissue with next generation sequencing towards presence of IDH and other mutations. | Other | Patient cohort |
Primary outcome
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
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.
1 secondary outcome
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).
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 7 Oct 2026.
- 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 Chondrosarcoma of the Bone, run by Medical University of Graz at 1 site in Austria.
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 2 inclusion and 1 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 7 Oct 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 Austria. 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?
NGS analysis of primary tumour tissue (time frame: Up to 12 weeks following biopsy/definite surgery). The study lists 2 primary outcomes in all. 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 7 Oct 2026.