Biomarker-based Algorithm for Diagnosis of Glioma

• Conditions: Glioma
• Interventions: Other: PCR (Polymerase Chain Reaction)

• Registration Number: NCT04194593
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

ATRX (X-linked mental retardation and alpha-thalassaemia syndrome protein) loss and pTERT (Telomerase reverse transcriptase) mutation are diagnostic markers of gliomas. However, 4 to 28% of gliomas shows none of these alterations. The aim of this project is to propose a new test able to detect the telomeric status for every glioma. Based on this test and other markers (such as mutation of IDH1 (isocitrate dehydrogenase 1) and IDH2 (isocitrate dehydrogenase 2)), investigators propose an algorithm, able to classify the main subtypes of gliomas (astrocytoma, oligodendroglioma and glioblastoma).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Last Update Submitted: 2019-12-09
• Study First Posted: 2019-12-11
• Last Update Posted: 2019-12-11
• Primary Completion: 2020-03-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patient with a diagnosis of glioma (retrospective),
• Patient with available biological material : extracted DNA and/or FFPE tissue and/or frozen sample.
• Samples are not required any more for diagnosis purpose
• Patient with informed consent

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Exclusion Criteria

• Patient with no informed consent
• Patients with no available biological sample

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glioma	PCR (Polymerase Chain Reaction)	FFPE (Formalin-Fixed Paraffin-Embedded) or frozen samples will be used for DNA extraction. Different gliomas tumors will be used (oligodendroglioma, astrocytomas, glioblastoma)

Primary Outcome Measures

Name	Time	Method
Determination of the prognosis and diagnosis values of a new qPCR (quantitative polymerase chain reaction) -based biological testing in glioma	1 year	An algorithm will be built, based on the result of this specific biological testing combined with other markers (determined in routine clinical testing). The algorithm parameters will be set using samples with a clear diagnosis (concordant molecular and immuno-histological markers). Then gliomas with uncertain diagnosis will be classified and the global overall survival will be predicted.; Biological testing will be performed during one year and the analyses in terms of disease outcome will be refreshed every year.

Trial Locations

Locations (1)

Institut de Pathologie Est, Biopathologie moléculaire, Hôpitaux Est, HCL; 🇫🇷 Bron, France