Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT04194593
Status:
UNKNOWN
Last Update Posted:
2019-12-11
First Post:
2019-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker-based Algorithm for Diagnosis of Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016133', 'term': 'Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2019-12-09', 'studyFirstSubmitQcDate': '2019-12-09', 'lastUpdatePostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the prognosis and diagnosis values of a new qPCR (quantitative polymerase chain reaction) -based biological testing in glioma', 'timeFrame': '1 year', 'description': 'An algorithm will be built, based on the result of this specific biological testing combined with other markers (determined in routine clinical testing). The algorithm parameters will be set using samples with a clear diagnosis (concordant molecular and immuno-histological markers). Then gliomas with uncertain diagnosis will be classified and the global overall survival will be predicted.\n\nBiological testing will be performed during one year and the analyses in terms of disease outcome will be refreshed every year.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma']}, 'descriptionModule': {'briefSummary': 'ATRX (X-linked mental retardation and alpha-thalassaemia syndrome protein) loss and pTERT (Telomerase reverse transcriptase) mutation are diagnostic markers of gliomas. However, 4 to 28% of gliomas shows none of these alterations. The aim of this project is to propose a new test able to detect the telomeric status for every glioma. Based on this test and other markers (such as mutation of IDH1 (isocitrate dehydrogenase 1) and IDH2 (isocitrate dehydrogenase 2)), investigators propose an algorithm, able to classify the main subtypes of gliomas (astrocytoma, oligodendroglioma and glioblastoma).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '300 samples of gliomas (FFPE and/or frozen tissues)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with a diagnosis of glioma (retrospective),\n* Patient with available biological material : extracted DNA and/or FFPE tissue and/or frozen sample.\n* Samples are not required any more for diagnosis purpose\n* Patient with informed consent\n\nExclusion Criteria:\n\n* Patient with no informed consent\n* Patients with no available biological sample'}, 'identificationModule': {'nctId': 'NCT04194593', 'acronym': 'TELOGNOSTIC', 'briefTitle': 'Biomarker-based Algorithm for Diagnosis of Glioma', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Development of a New Algorithm-based Classification for Glioma', 'orgStudyIdInfo': {'id': '69HCL18_0795'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glioma', 'description': 'FFPE (Formalin-Fixed Paraffin-Embedded) or frozen samples will be used for DNA extraction. Different gliomas tumors will be used (oligodendroglioma, astrocytomas, glioblastoma)', 'interventionNames': ['Other: PCR (Polymerase Chain Reaction)']}], 'interventions': [{'name': 'PCR (Polymerase Chain Reaction)', 'type': 'OTHER', 'description': 'Biological testing of FFPE (Formalin-Fixed Paraffin-Embedded) or frozen samples of tumors will be led. These tissues have been collected during the treatment of patients (for diagnostic purposes).\n\nA molecular analysis (polymerase chain reaction) is led on DNA extracted from FFPE/frozen conserved tissues, and a result is produced by the algorithm.', 'armGroupLabels': ['Glioma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Institut de Pathologie Est, Biopathologie moléculaire, Hôpitaux Est, HCL', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}