Non Invasive IDentification of Gliomas With IDH1 Mutation (IDASPE)
|ClinicalTrials.gov Identifier: NCT01703962|
Recruitment Status : Unknown
Verified February 2016 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Recruiting
First Posted : October 11, 2012
Last Update Posted : February 25, 2016
The recurrent mutation IDH1Arg132His leads to the cellular accumulation of D-2-hydroxyglutarate (2-HG), thus representing a diagnostic marker (this change is almost specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest.
The main objective is to identify the patients with IDH1 mutated glioma by three complementary approaches -genetic (identification of IDH1 mutation in plasmatic DNA), biochemical (2-HG dosage in the urine of patients) and radiological (2-HG
|Condition or disease|
|Non Invasive Diagnosis of Glioma|
Our preliminary results indicate an extremely high amount of D-2HG in gliomas and CSF of the patients, and therefore the possibility to detect its presence by spectro-MRI, and to establish a non-invasive diagnosis of glioma with IDH1 mutation. Our goal is to identify and quantify by high-field MRI spectroscopy the presence of D-2HG to identify gliomas with IDH1 mutation. In parallel, we developed a technique for selective amplification of the mutated form of IDH1 (COLD PCR): by combining this technique with digital PCR, we already are able to detect IDH1 mutation from free plasma DNA with a sensitivity of 58% and a specificity of 100%. At the same time we have shown that D-2HG levels in urine of patients correlate with the status of the tumor IDH1.
The main objective is to identify using this triple approach (detection of the mutation on plasma DNA detection, detection of urinary D-2HG, detection of tumor D-2HG by spectro-MRI) patients with IDH1arg132His mutation, the secondary objective is to evaluate the value of these markers for patients follow-up and for differentiating recurrence from treatment induced damage. 40 patients with grade II and grade III gliomas (20 mutated, 20 non mutated) will be included and followed up for one year (five measurements are planned).
The first interest is diagnostic: the presence of the IDH1Arg132His mutation allows the diagnosis of glioma. This information is particularly valuable in patients not amenable to biopsy, because of the location of the tumor considered at risk, the general condition of the patient or the co-morbidities and medications. We hope also with these parameters to better monitor patient's follow-up, and to have a new method to differentiate tumor recurrence and radionecrosis or post-radiation leukoencephalopathy.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Observational Model:||Case Control|
|Official Title:||Non Invasive IDentification of Gliomas With IDH1 Mutation by Free Plasmatic DNA Analysis, 2-hydroxyglutarate Dosage in the Urines and 2-hydroxyglutarate Detection by Brain SPEctro-MRI: Diagnostic and Follow-up Application (IDASPE)|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||September 2016|
|Patients with IDH1 R132H or wild type IDH1/IDH2 glioma|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703962
|Contact: Marc SANSON, MDPhDemail@example.com|
|GH Pitié-Salpêtrière, 47 Bd de l'Hopital,||Recruiting|
|Paris, Sélectionner..., France, 75013|
|Contact: Marc Sanson, MDPhD 33142160391 firstname.lastname@example.org|
|Sub-Investigator: Damien Galanaud, MD|
|Principal Investigator:||Marc SANSON, MDPhD||University of Pittsburgh|