Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 7:49 AM
Study NCT ID:
NCT06038760
Status:
TERMINATED
Last Update Posted:
2025-07-30
First Post:
2023-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D004806', 'term': 'Ependymoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D001254', 'term': 'Astrocytoma'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-03', 'size': 1020370, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-25T05:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor resections and blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2023-09-08', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Culture success rate of tumor cells', 'timeFrame': '1 week', 'description': 'The percentage of cultures in which ≥70% of viable tumor cells encapsulated post-isolation on day 0 are still alive on day 3 in the control cultures (no treatment) compared to the number of tumor samples successfully accepted at the study central lab.'}, {'measure': 'Culture rates success for immune cells', 'timeFrame': '1 week', 'description': 'The percentage of cultures in which ≥70% of viable immune cells plated post-extraction on day 0 are still alive on day 3 in the control cultures (no treatment) compared to the number of blood samples successfully accepted at the study central lab.'}, {'measure': 'Find correlations between ex vivo tumor culture or multi-omic biomarkers and real-world patient outcomes', 'timeFrame': '12 months', 'description': 'To correlate Pear assay results, biomarkers and outcomes'}, {'measure': "Assess Pear Bio's assay ability to categorise patients for below average or above average overall survival (OS", 'timeFrame': '12 months', 'description': 'Categorisation of patients into survival cohorts using the Pear assay'}, {'measure': 'Assess the correlation of omics biomarkers to patient PFS, ORR and/or OS', 'timeFrame': '12 months', 'description': 'Correlation between biomarkers and clinically relevant outcomes'}], 'primaryOutcomes': [{'measure': 'Differentiated ex vivo treatment response', 'timeFrame': '2 weeks', 'description': 'Measurement of treatment response in the Pear Assay'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival correlation', 'timeFrame': '1 year', 'description': 'The correlation between response in the Pear Bio system and PFS in patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['computer vision', 'cell culture', 'microtumor', 'functional testing', 'predictive biomarker', 'precision medicine', 'oncology', 'brain cancer'], 'conditions': ['Brain Tumor', 'Glioma, Malignant', 'Ependymoma', 'Oligodendroglioma', 'Glioblastoma']}, 'referencesModule': {'availIpds': [{'url': 'https://www.pearbio.com/pearglio', 'type': 'Study Protocol'}]}, 'descriptionModule': {'briefSummary': "Pear Bio has developed a 3D microtumor assay and computer vision pipeline through which the response of an individual patient's tumor to different anti-cancer regimens can be tested simultaneously ex vivo. This study will recruit patients with primary brain tumors who are due to undergo surgery.\n\nOncologists will be blinded to treatment response on the Pear Bio tool (the assay will be run in parallel with the patient's treatment). The primary objective of this study is to establish the ex vivo model and confirm whether approved therapies exhibit their intended mechanism of action in the model. Secondary objectives include correlating test results to patient outcomes, where available.", 'detailedDescription': 'This is a multicenter, observational pilot study that aims to determine the feasibility of using the Pear Bio tool in patients with primary solid brain tumors.\n\nPatients who are due to undergo clinically-mandated surgery will provide informed consent to donate excess tissue and a 40mL blood sample.\n\nThe samples will be tested on the Pear Bio tool while the patient receives their standard of care treatment. As such, for this study, the result from the Pear Bio tool will not be used to inform the choice of treatment and the treating oncologist will be blinded to the assay results.\n\nThe investigators will examine drug mechanism of action (MoA), differentiated response, and correlate that with outcomes seen in the patients treated in routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with primary solid brain tumor', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion:\n\n1. Patient diagnosed with operable brain cancer, thought likely to be primary solid brain tumor on imaging (grade 2 - 3 meningioma; grade 1 - 4 tumors otherwise) or with histologically proven primary malignant solid brain tumor\n2. Able to give written informed consent prior to admission to this study;\n3. Female or male aged ≥18 years;\n4. Patient consents to the use of their surgical sample and 40mL of whole blood for research purposes\n5. Surgical sample and yields ≥0.4g for the study\n6. Patient consents to providing histopathology data (e.g., confirmation of histological subtype as oligodendroglioma) and other pseudonymised health information including imaging, treatment and outcome data.\n\nExclusion:\n\n1. Inoperable or biopsy only\n2. Suspected lymphoma or myeloma, or grade 1 meningioma\n3. Preoperative haemoglobin levels below 120g/L\n4. Patients who have already received chemotherapy, targeted therapy, immunotherapy, or radiotherapy less than 30 days before date of surgery, unless as part of a clinical trial (requires per-patient sponsor approval)\n5. Recurrence of cancer originating from a site other than the brain\n6. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent."}, 'identificationModule': {'nctId': 'NCT06038760', 'acronym': 'PEAR-GLIO', 'briefTitle': 'Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ourotech, Inc.'}, 'officialTitle': 'Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)', 'orgStudyIdInfo': {'id': 'PEAR-GLIO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trial Cohort', 'description': 'Patients with a solid primary brain tumor due to undergo surgery as standard of care', 'interventionNames': ['Procedure: Resection']}], 'interventions': [{'name': 'Resection', 'type': 'PROCEDURE', 'description': 'Patients undergo a resection from a lesion, and give 40mL of blood', 'armGroupLabels': ['Trial Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W6 8RF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Matt Williams, FRCR PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Pseudonymised data will be shared between study sites, such as treatment and outcome data for each patient. No publication will be made revealing individual patient data; only group-level data will be published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ourotech, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}