CHORDOMES: Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT04486820
Collaborator
(none)
40
1
3
13.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Analysis Immunohistochemical

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

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Chordoma

Patients diagnosed with chordoma

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

Outcome Measures

Primary Outcome Measures

  1. Expression of PD-L1 [Baseline]

    measured by immunohistochemical method

  2. Expression of CD8 [Baseline]

    measured by immunohistochemical method

  3. Expression of CDX2 [Baseline]

    measured by immunohistochemical method

  4. Expression of INSM1 [Baseline]

    measured by immunohistochemical method

  5. Expression of FOXA1 [Baseline]

    measured by immunohistochemical method

Secondary Outcome Measures

  1. Histological type of tumor [Baseline]

    data collected in personal health records.

  2. Tumor location [Baseline]

    data collected in personal health records.

  3. survival of patients after diagnosis with or without progression [Baseline]

    data collected in personal health records.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients diagnosed with chordoma

  • Sufficient histological material available

  • Tumor expression of brachyury

Exclusion Criteria:
  • Insufficient histological material

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Saint-Etienne Saint-Étienne France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Georgia KARPATHIOU, MD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT04486820
Other Study ID Numbers:
  • 20CH028
First Posted:
Jul 27, 2020
Last Update Posted:
Jul 27, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2020