Biomarker-based Algorithm for Diagnosis of Glioma

NCT ID: NCT04194593

Last Updated: 2019-12-11

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-03-01

Brief Summary

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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

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Conditions

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Glioma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Glioma

FFPE (Formalin-Fixed Paraffin-Embedded) or frozen samples will be used for DNA extraction. Different gliomas tumors will be used (oligodendroglioma, astrocytomas, glioblastoma)

PCR (Polymerase Chain Reaction)

Intervention Type OTHER

Biological testing of FFPE (Formalin-Fixed Paraffin-Embedded) or frozen samples of tumors will be led. These tissues have been collected during the treatment of patients (for diagnostic purposes).

A molecular analysis (polymerase chain reaction) is led on DNA extracted from FFPE/frozen conserved tissues, and a result is produced by the algorithm.

Interventions

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PCR (Polymerase Chain Reaction)

Biological testing of FFPE (Formalin-Fixed Paraffin-Embedded) or frozen samples of tumors will be led. These tissues have been collected during the treatment of patients (for diagnostic purposes).

A molecular analysis (polymerase chain reaction) is led on DNA extracted from FFPE/frozen conserved tissues, and a result is produced by the algorithm.

Intervention Type OTHER

Eligibility Criteria

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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

Exclusion Criteria

* Patient with no informed consent
* Patients with no available biological sample
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de Pathologie Est, Biopathologie moléculaire, Hôpitaux Est, HCL

Bron, , France

Site Status

Countries

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France

Other Identifiers

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69HCL18_0795

Identifier Type: -

Identifier Source: org_study_id