NCT04486820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

July 22, 2020

Last Update Submit

July 22, 2020

Conditions

Keywords

ImmunohistochemicalPD-L1CD8CDX2INSM1FOXA1

Outcome Measures

Primary Outcomes (5)

  • Expression of PD-L1

    measured by immunohistochemical method

    Baseline

  • Expression of CD8

    measured by immunohistochemical method

    Baseline

  • Expression of CDX2

    measured by immunohistochemical method

    Baseline

  • Expression of INSM1

    measured by immunohistochemical method

    Baseline

  • Expression of FOXA1

    measured by immunohistochemical method

    Baseline

Secondary Outcomes (3)

  • Histological type of tumor

    Baseline

  • Tumor location

    Baseline

  • survival of patients after diagnosis with or without progression

    Baseline

Study Arms (1)

Chordoma

Patients diagnosed with chordoma

Other: Analysis Immunohistochemical

Interventions

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

Chordoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with chordoma

You may qualify if:

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

You may not qualify if:

  • \- Insufficient histological material

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Chordoma

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Georgia KARPATHIOU, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 27, 2020

Study Start

April 1, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations