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

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ClinicalTrials.gov Identifier: NCT04486820
Recruitment Status : Completed
First Posted : July 27, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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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
Chordoma 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
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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 : April 1, 2020
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Chordoma

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Expression of PD-L1 [ Time Frame: Baseline ]
    measured by immunohistochemical method

  2. Expression of CD8 [ Time Frame: Baseline ]
    measured by immunohistochemical method

  3. Expression of CDX2 [ Time Frame: Baseline ]
    measured by immunohistochemical method

  4. Expression of INSM1 [ Time Frame: Baseline ]
    measured by immunohistochemical method

  5. Expression of FOXA1 [ Time Frame: Baseline ]
    measured by immunohistochemical method


Secondary Outcome Measures :
  1. Histological type of tumor [ Time Frame: Baseline ]
    data collected in personal health records.

  2. Tumor location [ Time Frame: Baseline ]
    data collected in personal health records.

  3. survival of patients after diagnosis with or without progression [ Time Frame: Baseline ]
    data collected in personal health records.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with chordoma
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Insufficient histological material

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486820


Locations
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France
CHU de Saint-Etienne
Saint-Étienne, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Georgia KARPATHIOU, MD CHU SAINT-ETIENNE
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04486820    
Other Study ID Numbers: 20CH028
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Immunohistochemical
PD-L1
CD8
 CDX2
INSM1
FOXA1
Additional relevant MeSH terms:
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Chordoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms