Non Invasive Detection of IDH1/2 Mutation in Gliomas
IDASPE
Non Invasive IDentification of Gliomas With IDH1/2 Mutation by Analysis of Circulating Plasmatic DNA, D-2-hydroxyglutarate Dosage in Biological Liquids and Detection by Brain SPEctro-MRI: Impact for Diagnosis and Follow-up
1 other identifier
interventional
40
1 country
1
Brief Summary
This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG detection by Brain Spectro MRI. In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor mutational status and D-2HG. In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma, urine dosages overtime in order to correlate results with the response to treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 27, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedSeptember 20, 2017
December 1, 2016
3 years
April 27, 2015
September 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
D-2HG quantified by spectroMRI the measure of the ratio between two pics D-2HG and creatine [Time Frame: 3 months after surgery] [Designated as safety issue: No]
This ratio D-2HG/creatine will be correlated with the dosage obtained in tumor tissue performed within three months after the surgery
3 months after surgery
Secondary Outcomes (1)
SpectroMRI [Time Frame: evolution over 12 months] [Designated as safety issue: No]
evolution over 12 months
Study Arms (1)
IDH1/IDH2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Affiliation to a social security system
- Patient≥ 18 years old
- Written informed consent
- One of the two situations:
- presumed grade II-III glioma candidate to surgery (group 1)
- IDH1/IDH2 mutated grade II-III gliomas, candidate to chemotherapy or radiotherapy treatment, or simple follow-up (group 2)
- Evaluable tumoral mass min diameter \>2 cm (FLAIR)
- PKPS \> 60
You may not qualify if:
- Contra-indication to MRI
- Patient unable to give an written Informed Consent
- Patient under guardianship or deprived of freedom
- For group 2: patient already included in group 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Sanson, MD, PhD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2015
First Posted
November 5, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
September 20, 2017
Record last verified: 2016-12