Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT05100602
Status:
COMPLETED
Last Update Posted:
2021-11-22
First Post:
2021-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-01', 'size': 788269, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-12T00:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1192}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of the Genetron TERT PCR Kit', 'timeFrame': '3 months', 'description': 'The main purpose of this study is: by evaluating the Genetron TERT PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma, Malignant']}, 'descriptionModule': {'briefSummary': 'The purpose of this trail is to evaluate the performance of Genetron TERT PCR Kit in Glioma patients using real-time PCR method.', 'detailedDescription': 'This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with the Genetron TERT PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method.Combined with the results of clinicopathological classification, the incidence of C228T and C250T mutations of TERT promoter genes in different subtypes was counted to evaluate the clinical application performance of the Genetron TERT PCR Kit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Enroll cases in strict accordance with the requirements of the study\n2. The remaining samples after routine clinical testing\n3. The collection and processing of samples meet the requirements of standard laboratory operations and product instructions\n4. The relevant information of the sample is complete, including sample number, gender, age, and possible clinical diagnosis information\n5. Each sample must have HE staining results (hematoxylin-eosin staining)\n6. Pathological examination diagnosed as glioma, other brain tumors or normal tissues\n7. Number of samples: 10 pieces of each sample with a thickness of 10μm, and the tumor content is not less than 50%\n\nExclusion Criteria:\n\n1. The sample information is not complete\n2. Severely contaminated samples\n3. Samples that do not meet the requirements of sample collection and processing'}, 'identificationModule': {'nctId': 'NCT05100602', 'briefTitle': 'Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genetron Health'}, 'officialTitle': 'Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients', 'orgStudyIdInfo': {'id': '2016063011442779'}}, 'contactsLocationsModule': {'locations': [{'city': 'Jilin', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Huashan Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 35.1221, 'lon': 105.48032}}, {'city': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genetron Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Huashan Hospital', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}