Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-02 @ 12:55 AM
Study NCT ID:
NCT02307604
Status:
WITHDRAWN
Last Update Posted:
2019-06-24
First Post:
2014-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SPECTAbrain: Screening Patients With Brain Tumors for Efficient Clinical Trial Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'FFPE blocks of tumour tissue Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'This study has been merged with 1553 SPECTA, in which brain patients are enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-20', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with brain malignancy', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Brain tumor', 'Biomarkers', 'Screening'], 'conditions': ['Brain Neoplasms']}, 'descriptionModule': {'briefSummary': 'The SPECTAbrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. Efficiency is promoted through the creation of a clinical database of brain tumor patients and the respective human biological material biobank for molecular characterization. The main objectives are to:\n\n* Allocate patients to clinical trials according to the clinical characteristics and molecular profile of their tumor;\n* Identify or validate new molecularly defined subgroups of tumors;\n* Investigate the prevalence of novel biomarkers to plan future clinical trials;\n* Enable exploratory/future research;\n* Facilitate establishment of quality-assured and validated tests for Central Nervous System (CNS) tumor biomarkers;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pathologically confirmed brain cancer at any stage.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed newly diagnosed primary CNS tumors, with a focus on diffuse gliomas of grades II, III and IV, meningiomas from patients who are candidates for pharmacotherapy, and rare CNS tumors;\n* Availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary and/or recurrent tumor and/or metastasis, obtained at the time of surgery or biopsy; minimal amount requested is detailed in the HBM guidelines. Inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;\n* At least three months life expectancy;\n* Written informed consent according to ICH/GCP and national/local regulations;\n* Absence of exclusion criteria, such as active hepatitis B/C or HIV, second malignancies, severe organ dysfunction, or other comorbidities that will prevent inclusion into clinical trials.'}, 'identificationModule': {'nctId': 'NCT02307604', 'acronym': 'SPECTAbrain', 'briefTitle': 'SPECTAbrain: Screening Patients With Brain Tumors for Efficient Clinical Trial Access', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Screening Platform of EORTC for Clinical Trials Access in Brain Tumors', 'orgStudyIdInfo': {'id': 'EORTC-1313'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Brain cancer', 'description': 'Patients with diagnosis of brain cancer at any stage', 'interventionNames': ['Genetic: Tumour markers testing']}], 'interventions': [{'name': 'Tumour markers testing', 'type': 'GENETIC', 'armGroupLabels': ['Brain cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'FR 59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': 'FR 75651', 'city': 'Paris', 'country': 'France', 'facility': 'Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Michael Weller, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UniversitaetsSpital Zurich - Department of Neurology, Zurich, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}