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Biomarker-based Algorithm for Diagnosis of Glioma

Development of a New Algorithm-based Classification for Glioma

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04194593
Acronym
TELOGNOSTIC
Enrollment
300
Registered
2019-12-11
Start date
2018-12-01
Completion date
2021-03-01
Last updated
2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

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).

Interventions

OTHERPCR (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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of the prognosis and diagnosis values of a new qPCR (quantitative polymerase chain reaction) -based biological testing in glioma1 yearAn 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026