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Non Invasive IDentification of Gliomas With IDH1 Mutation (IDASPE)

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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
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:

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

Detailed Description:

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
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Patients with IDH1 R132H or wild type IDH1/IDH2 glioma

Biospecimen Retention:   Samples With DNA
Plasma samples containing free DNA fragments Urine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the active file of patients with glioma II or III, followed at the Pitié-Salpetrière Hospital, and whose status is known for IDH1.

Inclusion Criteria:

Inclusion Criteria

  • Affiliated to Health Insurance regimen (sécurité sociale)
  • Patient of 18 years or more
  • written informed consent
  • Glioma grade II or III histologically proven
  • Frozen samples available
  • Known status IDH1/IDH2
  • Presence of a measurable residual tumor (> 2 cm in diameter FLAIR)
  • Karnofsky Performance Status (KPS)> 60

Exclusion Criteria:

  • Contraindication to MRI *
  • The rare patients with IDH2 mutation or with non Arg132His IDH1 mutation will be excluded
  • Inability to provide informed consent
  • Patient under guardianship or deprived of liberty by court

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): NCT01703962

Contact: Marc SANSON, MDPhD 33142160391 marc.sanson@psl.aphp.fr

GH Pitié-Salpêtrière, 47 Bd de l'Hopital, Recruiting
Paris, Sélectionner..., France, 75013
Contact: Marc Sanson, MDPhD    33142160391    marc.sanson@psl.aphp.fr   
Sub-Investigator: Damien Galanaud, MD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Marc SANSON, MDPhD University of Pittsburgh

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01703962     History of Changes
Other Study ID Numbers: C11-28
2011-A01356-35 ( Registry Identifier: IDRCB )
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue