ChordomaCHORDOMESNCT04486820
Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care
An observational study of Chordoma, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Chordomas are very rare malignant tumors, chemo-resistant with high propensity for recurrence. The role of immunotherapy in these patients remains largely unexplored while PD-L1 and CD8 status in the micro-environment of chordomas is basically not known. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chordoma
- What is being tested?
- Analysis Immunohistochemical
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with chordoma
Who may be able to join
- Patients diagnosed with chordoma
- Sufficient histological material available
- Tumor expression of brachyury
Who cannot join
- Insufficient histological material
Trial locations and contacts
1 site in 1 country.
About this study
Chordomas are very rare malignant tumors, chemo-resistant with high propensity for recurrence. The role of immunotherapy in these patients remains largely unexplored while PD-L1 and CD8 status in the micro-environment of chordomas is basically not known. Similarly, this tumor often poses diagnostic difficulties due to its resemblance with metastasis or chondrosarcoma, thus, it would be useful to know the expression status of factors used during the work-up of metastatic or mesenchymal tumors, like CDX2, INSM1 and FOXA1, which remains unknown for chordomas. Thus, the aim of the study is to explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression in a series of chordomas and compare it with clinico-pathological and prognostic features.
Read the detailed description
Retrospective, non-interventional study. A series of chordomas will be analyzed for detailed histologic features and for various immunohistochemical factors and results will be compared with clinical factors, like overall and disease-free survival.
- Conditions
- Chordoma
- Being tested
- Analysis Immunohistochemical
- Keywords
- Immunohistochemical, PD-L1, CD8, CDX2, INSM1, FOXA1
- Medical subject headings
- Chordoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis ImmunohistochemicalOther
Analysis of histological material for immunohistochemical study. To explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression
| Study group | Role | What they receive |
|---|---|---|
| Chordoma | Patients diagnosed with chordoma Receives: Other: Analysis Immunohistochemical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of PD-L1
measured by immunohistochemical method
Measured: Baseline
Expression of CD8
measured by immunohistochemical method
Measured: Baseline
Expression of CDX2
measured by immunohistochemical method
Measured: Baseline
Expression of INSM1
measured by immunohistochemical method
Measured: Baseline
Expression of FOXA1
measured by immunohistochemical method
Measured: Baseline
Secondary outcomes (3)
Histological type of tumor
data collected in personal health records.
Measured: Baseline
Tumor location
data collected in personal health records.
Measured: Baseline
survival of patients after diagnosis with or without progression
data collected in personal health records.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Apr 2020
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChordomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georgia KARPATHIOU, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486820
- Sponsor's protocol ID
- 20CH028
- Acronym
- CHORDOMES
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 27 Jul 2020
- 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 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care
- ClinicalTrials.gov ID
- NCT04486820
- Acronym / sponsor ID
- CHORDOMES / 20CH028
- Conditions
- Chordoma
- Keywords
- Immunohistochemical, PD-L1, CD8, CDX2, INSM1, FOXA1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 27 Jul 2020 (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.
Chordomas are very rare malignant tumors, chemo-resistant with high propensity for recurrence. The role of immunotherapy in these patients remains largely unexplored while PD-L1 and CD8 status in the micro-environment of chordomas is basically not known. Similarly, this tumor often poses diagnostic difficulties due to its resemblance with metastasis or chondrosarcoma, thus, it would be useful to know the expression status of factors used during the work-up of metastatic or mesenchymal tumors, like CDX2, INSM1 and FOXA1, which remains unknown for chordomas. Thus, the aim of the study is to explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression in a series of chordomas and compare it with clinico-pathological and prognostic features.
Detailed description
Retrospective, non-interventional study. A series of chordomas will be analyzed for detailed histologic features and for various immunohistochemical factors and results will be compared with clinical factors, like overall and disease-free survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chordoma | – | Other: Analysis ImmunohistochemicalPatients diagnosed with chordoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with chordoma
Key inclusion criteria (3 listed)
- Patients diagnosed with chordoma
- Sufficient histological material available
- Tumor expression of brachyury
Key exclusion criteria (1 listed)
- Insufficient histological material
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 |
|---|---|---|
| Analysis ImmunohistochemicalAnalysis of histological material for immunohistochemical study. To explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression | Other | Chordoma |
Primary outcome
Expression of PD-L1
Time frame: Baseline
measured by immunohistochemical method
Expression of CD8
Time frame: Baseline
measured by immunohistochemical method
Expression of CDX2
Time frame: Baseline
measured by immunohistochemical method
Expression of INSM1
Time frame: Baseline
measured by immunohistochemical method
Expression of FOXA1
Time frame: Baseline
measured by immunohistochemical method
3 secondary outcomes
Histological type of tumor
Time frame: Baseline
Tumor location
Time frame: Baseline
survival of patients after diagnosis with or without progression
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Chordoma
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingObservational study
Children and Adults With Chordoma
Chordoma
Active, not recruitingObservational study
Genetic Clues to Chordoma Etiology: A Protocol to Identify Sporadic Chordoma Patients for Studies of Cancer-Susceptibility Genes
Genes, Sporadic Chordoma
RecruitingObservational study
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
Chordoma of Spine, Chordoma of Skull Base
Active, not recruiting
High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
Chordoma of Spine, Chordoma of Sacrum
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. This study is not recruiting at the moment.
Georgia KARPATHIOU, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Chordoma, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 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: finished, as of the sponsor's last update on 27 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of PD-L1 (time frame: Baseline). The study lists 5 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 27 Jul 2020.