Biomarker-based Algorithm for Diagnosis of Glioma

Glioma Clinical Trial

— TELOGNOSTIC  

Official title:

Development of a New Algorithm-based Classification for Glioma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04194593
• Other study ID #: 69HCL18_0795
• Status: Active, not recruiting
• Start date: December 1, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: December 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Institut de Pathologie Est, Biopathologie moléculaire, Hôpitaux Est, HCL	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the prognosis and diagnosis values of a new qPCR (quantitative polymerase chain reaction) -based biological testing in glioma	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.	1 year