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
|Condition or disease||Intervention/treatment|
|Glioma||Other: PCR (Polymerase Chain Reaction)|
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|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|
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.
- 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.
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
|Institut de Pathologie Est, Biopathologie moléculaire, Hôpitaux Est, HCL|
|Bron, France, 69677|