Non Invasive IDentification of Gliomas With IDH1 Mutation (IDASPE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01703962
First received: October 8, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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
Non Invasive Diagnosis of Glioma

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Biospecimen Retention:   Samples With DNA

Plasma samples containing free DNA fragments Urine


Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with IDH1 R132H or wild type IDH1/IDH2 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01703962

Locations
France
GH Pitié-Salpêtrière, 47 Bd de l'Hopital,
Paris, Sélectionner..., France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Marc SANSON, MDPhD University of Pittsburgh
  More Information

No publications provided

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
Study First Received: October 8, 2012
Last Updated: October 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Glioma
IDH1
Spectroscopy
Plasma

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

ClinicalTrials.gov processed this record on August 28, 2014