Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care

Chordoma Clinical Trial

— CHORDOMES  

Official title:

Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486820
• Other study ID #: 20CH028
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with chordoma

• Sufficient histological material available

• Tumor expression of brachyury

Exclusion Criteria:

• Insufficient histological material

Related Conditions & MeSH terms

• Chordoma

Intervention

Other:
• Analysis Immunohistochemical
Analysis of histological material for immunohistochemical study. To explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of PD-L1	measured by immunohistochemical method	Baseline
Primary	Expression of CD8	measured by immunohistochemical method	Baseline
Primary	Expression of CDX2	measured by immunohistochemical method	Baseline
Primary	Expression of INSM1	measured by immunohistochemical method	Baseline
Primary	Expression of FOXA1	measured by immunohistochemical method	Baseline
Secondary	Histological type of tumor	data collected in personal health records.	Baseline
Secondary	Tumor location	data collected in personal health records.	Baseline
Secondary	survival of patients after diagnosis with or without progression	data collected in personal health records.	Baseline