Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care

Completed

• Conditions: Chordoma

• Registration Number: NCT04486820
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

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 Timeline

• Study Start: 2020-04-01
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Last Update Submitted: 2020-07-22
• Study First Posted: 2020-07-27
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients diagnosed with chordoma
• Sufficient histological material available
• Tumor expression of brachyury

Exclusion Criteria

• Insufficient histological material

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expression of INSM1	Baseline	measured by immunohistochemical method
Expression of PD-L1	Baseline	measured by immunohistochemical method
Expression of CD8	Baseline	measured by immunohistochemical method
Expression of FOXA1	Baseline	measured by immunohistochemical method
Expression of CDX2	Baseline	measured by immunohistochemical method

Secondary Outcome Measures

Name	Time	Method
Histological type of tumor	Baseline	data collected in personal health records.
survival of patients after diagnosis with or without progression	Baseline	data collected in personal health records.
Tumor location	Baseline	data collected in personal health records.

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France