Biomarker-based Algorithm for Diagnosis of Glioma

NCT04194593 | Unknown

• 1 other identifier: 69HCL18_0795
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Glioma

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

Other: PCR (Polymerase Chain Reaction)

Interventions

PCR (Polymerase Chain Reaction) 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.

Glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

300 samples of gliomas (FFPE and/or frozen tissues)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69677, France

Location

MeSH Terms

Conditions

Glioma

Interventions

Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: December 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)