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Biomarker-based Algorithm for Diagnosis of Glioma (TELOGNOSTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194593
Recruitment Status : Active, not recruiting
First Posted : December 11, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Glioma Other: PCR (Polymerase Chain Reaction)

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Development of a New Algorithm-based Classification for Glioma
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)

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.





Primary Outcome Measures :
  1. Determination of the prognosis and diagnosis values of a new qPCR (quantitative polymerase chain reaction) -based biological testing in glioma [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
300 samples of gliomas (FFPE and/or frozen tissues)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194593


Locations
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France
Institut de Pathologie Est, Biopathologie moléculaire, Hôpitaux Est, HCL
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04194593    
Other Study ID Numbers: 69HCL18_0795
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue