Completed

IDASPENon 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)

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Neoplasms+5

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: March 2012
See protocol details

Summary

Principal SponsorInstitut National de la Santé Et de la Recherche Médicale, France
Last updated: August 26, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: March 14, 2012

Actual date on which the first participant was enrolled.

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.

NCT01703962
Principal SponsorInstitut National de la Santé Et de la Recherche Médicale, France
Last updated: August 26, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, NeuroepithelialGlioma

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

GH Pitié-Salpêtrière, 47 Bd de l'Hopital,

Paris, FranceOpen GH Pitié-Salpêtrière, 47 Bd de l'Hopital, in Google Maps
CompletedOne Study Center