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OpenTrials
Completed

NCT Number: NCT04486820

Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care

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.

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Key information

Conditions

Chordoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint-Etienne

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Insufficient histological material

Treatment and study plan

Analysis Immunohistochemical

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: CHORDOMES

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2020
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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