Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
976 participants
OBSERVATIONAL
2019-12-05
2021-12-20
Brief Summary
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Detailed Description
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Moreover, to expend the application of the diagnostic algorithm to surgical practice, we developed a fast detection assay that could detect hotspot somatic mutations in IDH and TERT within 25 minutes and can discriminate TERT and IDH mutations from wild-type alleles with a minimum variant allele frequency (VAF) of 0.2% and 0.5%, respectively. We further validate the simplified diagnostic algorithm on frozen tissue of 223 patients with glioma in another retrospective cohort and performed this assay to evaluate the accuracy of the rapid assay.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Discovery cohort
Retrospective frozen tissue and paired peripheral blood samples were obtained from the Huashan Glioma Biobank between October 2010 and August 2018. A total of 753 patients diagnosed with supratentorial diffuse glioma (WHO grade 2-4) aged 18-80 years were selected for the study.
Detection of IDH and TERT mutation
Detection of IDH and TERT mutation using frozen glioma tissues
Validation cohort
From January to July 2021, 223 frozen tissue samples were retrieved from the Huashan Glioma Biobank. In addition, 107 frozen tumor samples were used to assess the detection accuracy of the IDH and TERTp mutation rapid test. The accuracy of this qPCR-based rapid test was further confirmed by Sanger and targeted sequencing.
Detection of IDH and TERT mutation
Detection of IDH and TERT mutation using frozen glioma tissues
Interventions
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Detection of IDH and TERT mutation
Detection of IDH and TERT mutation using frozen glioma tissues
Eligibility Criteria
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Inclusion Criteria
* Glioma patient with long-term follow-up data and intact clinical data
Exclusion Criteria
* Glioma patient without long-term follow-up data or intact clinical data
18 Years
80 Years
ALL
No
Sponsors
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Jinsong Wu
OTHER
Responsible Party
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Jinsong Wu
Prof.
Principal Investigators
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Jin-song Wu, MD & PhD
Role: STUDY_CHAIR
Huashan Hospital
Locations
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Huashan Hospital
Shanghai, Jingan District, China
Countries
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References
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Wu J, Wu S, Cao D, Xiong Z, Zhang J, Zou Y, Wu Z, Nie Y, Luo C, Yao Y, Song Y, Jiao Y, Chen H, Ma H, Kang D, Mao Y, Yan H. Rapid diagnosis of adult-type diffuse glioma using a layered scheme. BMC Med. 2025 Jun 2;23(1):325. doi: 10.1186/s12916-025-04124-9.
Other Identifiers
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KY2019-539
Identifier Type: -
Identifier Source: org_study_id
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