Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT05259332
Status:
UNKNOWN
Last Update Posted:
2022-02-28
First Post:
2022-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Tumor samples (atypical meningiomas WHO grade II)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'through study completion an average of 5 years.', 'description': 'Progression being defined by a growth (mm3) of the tumor objectified by imaging.'}], 'secondaryOutcomes': [{'measure': 'Tumor volume assessed by imaging pre- and post-operative', 'timeFrame': 'before and within 3 months after surgery', 'description': 'mm3; RECIST criteria'}, {'measure': 'mRNA quantities of transcripts of interest', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'µg.mL-1'}, {'measure': 'Radiotherapy-induced toxicity', 'timeFrame': 'within 5 years after radiotherapy', 'description': 'CTCAE scale (Common Terminology Criteria for Adverse Events) v 4.0'}, {'measure': 'Dose of corticosteroids before and after radiotherapy', 'timeFrame': 'within 6 months before and after radiotherapy', 'description': 'in mg'}, {'measure': 'Intra-observer, inter-observer and inter-laboratory intra-class correlation coefficients of immunohistochemical markers.', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Kappa coefficient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcriptome'], 'conditions': ['Meningioma Atypical']}, 'descriptionModule': {'briefSummary': 'Determine by a transcriptomic approach new prognostic and predictive markers in atypical meningiomas (WHO grade II).\n\nRetrospective observational study, on a cohort of 85 atypical meningiomas. Transcriptomic study first, on cryopreserved tumor samples. Then identify, thanks to the transcriptomic study, prognostic and predictive factors (study of the link between the quantity of certain RNA transcripts and progression-free survival). Finally, set up immunohistochemical applications, which can be used routinely by the pathologist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients included in the collection of biological samples from the Department of Pathological Anatomy and Cytology and the Biological Resource Center (CHRU Nancy).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary operated patients for an atypical meningioma (WHO grade II) in the Neurosurgery department of the University Hospital of Nancy.\n* At least one postoperative follow-up visit.\n* Adult patients (\\>18 yo) at the time of the intervention.\n* Surgical excision.\n\nExclusion Criteria:\n\n* History of meningioma in the same location.\n* Neo-adjuvant treatment.\n* Absence of non-objection form.'}, 'identificationModule': {'nctId': 'NCT05259332', 'acronym': 'TransMenAtyp', 'briefTitle': 'Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas and Immunohistochemical Applications', 'orgStudyIdInfo': {'id': '2020PI026'}}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Lorraine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume GAUCHOTTE, PU-PH', 'role': 'CONTACT', 'email': 'guillaume.gauchotte@univ-lorraine.fr', 'phone': '+33 3 83 65 60 17'}, {'name': 'Emilie BECKER, Resident', 'role': 'CONTACT', 'email': 'emilie.becker54@gmail.com', 'phone': '+33 6 73 11 96 42'}], 'facility': 'Guillaume GAUCHOTTE', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Guillaume GAUCHOTTE, PUPH', 'role': 'CONTACT', 'email': 'g.gauchotte@univ-lorraine.fr', 'phone': '+33 3 83 65 60 17'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University professor and Hospital practitioner', 'investigatorFullName': 'Guillaume GAUCHOTTE', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}