Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-28 @ 11:19 AM
Study NCT ID:
NCT06043232
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D053842', 'term': 'Microsatellite Instability'}], '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'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D042822', 'term': 'Genomic Instability'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706173', 'term': 'lentiviral minigene vaccine of COVID-19 coronavirus'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcriptomics', 'timeFrame': '36 months', 'description': 'The issues collected will be used for transcriptome sequencing to measure gene expression level.'}, {'measure': 'Immunomics', 'timeFrame': '36 months', 'description': 'The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes'}, {'measure': 'Proteomics', 'timeFrame': '36 months', 'description': 'The issues collected will be used for TCR/BCR sequencing to measure gene expression level in protein'}, {'measure': 'Radiomics', 'timeFrame': '36 months', 'description': 'The features from images will be extracted using algorithm of Deep-learning or Radiomics'}, {'measure': 'IHC analysis', 'timeFrame': '36 months', 'description': 'Different expression level of proteins (CD3,CD8,B7-H4, MMR proteins) in Gliomas with different grades and molecular subgroups (300 cases) will be measured using immunohistochemical.'}, {'measure': 'Genomics', 'timeFrame': '36 months', 'description': 'The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glioblastoma multiforme', 'DC vaccine', 'Mismatch repair', 'Microsatellite instability', 'Biomarker'], 'conditions': ['Glioma']}, 'descriptionModule': {'briefSummary': 'Glioblastoma (GBM) is the most malignant primary intracranial tumor with a median survival of about 18 months, and new therapies are urgently needed. Tumor vaccines has been shown to improve survival of GBM, but not all patients can benefit from vaccine treatment and biomarkers are urgently needed. Deletion of mismatch repair (MMR) protein and microsatellite instability (MSI) state are important features in the biological evolution of GBM, and may be used as markers for tumor vaccine. Therefore, this project will collect samples from GBM patients before and after vaccine treatment respectively, and evaluate the role of MMR/MSI gene phenotype in predicting vaccine efficacy and the potential molecular mechanism. Moreover, MMR/MSI phenotypes will be assessed by deep-learning and radiomics using images to establish noninvasive markers for vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing glioma surgery at Huashan Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patients with glioma in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled\n\n1. They were 18-80 years old, male and female;\n2. The pathological results of frozen section during operation were gliomas (20 cases of who grade II, II and IV, respectively);\n3. Tissue (6 mm \\* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;\n4. Sign informed consent.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will not be included in this study:\n\n1. Participants in other clinical trials;\n2. Pregnant women.'}, 'identificationModule': {'nctId': 'NCT06043232', 'briefTitle': 'MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'The Role and Mechanism of MMR/MSI Phenotypes in Evaluating Vaccine Benefit in Glioblastoma', 'orgStudyIdInfo': {'id': 'KY2023-520'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'glioma patients with routine surgery', 'description': 'surgery'}, {'label': 'glioma patients with DC vaccine', 'description': 'surgery and DC vaccine', 'interventionNames': ['Biological: DC vaccine']}], 'interventions': [{'name': 'DC vaccine', 'type': 'BIOLOGICAL', 'description': 'DC vaccine produced by the Team', 'armGroupLabels': ['glioma patients with DC vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Yao', 'role': 'CONTACT', 'email': 'yu_yao03@126.com', 'phone': '86-021-5288-9999'}], 'facility': 'Huashan Hospital，Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Di Chen, MD', 'role': 'CONTACT', 'email': 'dichen18@fudan.edu.cn', 'phone': '86-021-5288-9999'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yu Yao, MD', 'investigatorAffiliation': 'Huashan Hospital'}}}}