Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-09 @ 8:37 AM
Study NCT ID:
NCT04486820
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2020-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002817', 'term': 'Chordoma'}], 'ancestors': [{'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression of PD-L1', 'timeFrame': 'Baseline', 'description': 'measured by immunohistochemical method'}, {'measure': 'Expression of CD8', 'timeFrame': 'Baseline', 'description': 'measured by immunohistochemical method'}, {'measure': 'Expression of CDX2', 'timeFrame': 'Baseline', 'description': 'measured by immunohistochemical method'}, {'measure': 'Expression of INSM1', 'timeFrame': 'Baseline', 'description': 'measured by immunohistochemical method'}, {'measure': 'Expression of FOXA1', 'timeFrame': 'Baseline', 'description': 'measured by immunohistochemical method'}], 'secondaryOutcomes': [{'measure': 'Histological type of tumor', 'timeFrame': 'Baseline', 'description': 'data collected in personal health records.'}, {'measure': 'Tumor location', 'timeFrame': 'Baseline', 'description': 'data collected in personal health records.'}, {'measure': 'survival of patients after diagnosis with or without progression', 'timeFrame': 'Baseline', 'description': 'data collected in personal health records.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunohistochemical', 'PD-L1', 'CD8', 'CDX2', 'INSM1', 'FOXA1'], 'conditions': ['Chordoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with chordoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with chordoma\n* Sufficient histological material available\n* Tumor expression of brachyury\n\nExclusion Criteria:\n\n\\- Insufficient histological material'}, 'identificationModule': {'nctId': 'NCT04486820', 'acronym': 'CHORDOMES', 'briefTitle': 'Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care', 'orgStudyIdInfo': {'id': '20CH028'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chordoma', 'description': 'Patients diagnosed with chordoma', 'interventionNames': ['Other: Analysis Immunohistochemical']}], 'interventions': [{'name': 'Analysis Immunohistochemical', 'type': 'OTHER', 'description': 'Analysis of histological material for immunohistochemical study. To explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression', 'armGroupLabels': ['Chordoma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Georgia KARPATHIOU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}