GliomaIDASPENCT02597335
Non Invasive Detection of IDH1/2 Mutation in Gliomas
A study testing Spectro-MRI, Dosage of free circulating plasmatic DNA and Dosage of D-2HG in the urine in people with Glioma and IDH1/IDH2 Mutation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, IDH1/IDH2 Mutation
- What is being tested?
- Spectro-MRI, Dosage of free circulating plasmatic DNA and Dosage of D-2HG in the urine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
Marc Sanson, MD, PhD, +331 42 16 03 91
About this study
Official title: 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
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.
Read the detailed description
The aim of this trial is to develop and validate a non invasive diagnostic approach of IDH1 mutated gliomas. It will evaluate the specificity and sensitivity of D-2HG detection by Brain Spectro MRI. This approach will be coupled with mutation detection from free plasmatic DNA and D-2HG dosage in urine samples.
The primary end-point is the quantification of D-2HG by spectro-MRI, and the correlation with the dosage of D-2HG in the tumor fragment, and the mutational status (group 1: 25 patients).
The secondary endpoints include:
- longitudinal analysis Spectro-MRI overtime (12 months) correlation with radiological evolution and the response to treatment (group 2: 15 patients)
- Differentiation of tumor recurrence from radiation induced changes
- Confrontation of Spectro-MRI, D-2HG dosages and IDH mutation detection from plasma DNA, and elaboration of a combined score of prediction
- Conditions
- Glioma, IDH1/IDH2 Mutation
- Being tested
- Spectro-MRI, Dosage of free circulating plasmatic DNA, Dosage of D-2HG in the urine
- Keywords
- Glioma, IDH1/IDH2 mutation, Spectroscopy MRI, D-2-hydroxyglutarate, Free circulating DNA
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectro-MRIRadiation
Spectro-MRI for D-2HG detection
Dosage of free circulating plasmatic DNAOther
Dosage of D-2HG in the urineOther
| Study group | Role | What they receive |
|---|---|---|
| IDH1/IDH2 | Experimental | Not described Receives: Radiation: Spectro-MRI; Other: Dosage of free circulating plasmatic DNA; Other: Dosage of D-2HG in the urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after surgery
Secondary outcomes (1)
SpectroMRI [Time Frame: evolution over 12 months] [Designated as safety issue: No]
The ratio D-2HG/creatine will be evaluated overtime and correlated with radiological evolution and the response to treatment (group 2: 15 patients) every four months
Measured: evolution over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Sanson, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597335
- Sponsor's protocol ID
- P120141
- Acronym
- IDASPE
- Status last verified
- Dec 2016
- First submitted
- 27 Apr 2015
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02597335
- Acronym / sponsor ID
- IDASPE / P120141
- Conditions
- Glioma, IDH1/IDH2 Mutation
- Keywords
- Glioma, IDH1/IDH2 mutation, Spectroscopy MRI, D-2-hydroxyglutarate, Free circulating DNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this trial is to develop and validate a non invasive diagnostic approach of IDH1 mutated gliomas. It will evaluate the specificity and sensitivity of D-2HG detection by Brain Spectro MRI. This approach will be coupled with mutation detection from free plasmatic DNA and D-2HG dosage in urine samples.
The primary end-point is the quantification of D-2HG by spectro-MRI, and the correlation with the dosage of D-2HG in the tumor fragment, and the mutational status (group 1: 25 patients).
The secondary endpoints include:
- longitudinal analysis Spectro-MRI overtime (12 months) correlation with radiological evolution and the response to treatment (group 2: 15 patients)
- Differentiation of tumor recurrence from radiation induced changes
- Confrontation of Spectro-MRI, D-2HG dosages and IDH mutation detection from plasma DNA, and elaboration of a combined score of prediction
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IDH1/IDH2 | Experimental | Radiation: Spectro-MRI, Other: Dosage of free circulating plasmatic DNA, Other: Dosage of D-2HG in the urine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Affiliation to a social security system
- Patient≥ 18 years old
- Written informed consent
- One of the two situations:
- Evaluable tumoral mass min diameter >2 cm (FLAIR)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectro-MRISpectro-MRI for D-2HG detection | Radiation | IDH1/IDH2 |
| Dosage of free circulating plasmatic DNA | Other | IDH1/IDH2 |
| Dosage of D-2HG in the urine | Other | IDH1/IDH2 |
Primary outcome
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]
Time frame: 3 months after surgery
This ratio D-2HG/creatine will be correlated with the dosage obtained in tumor tissue performed within three months after the surgery
1 secondary outcome
SpectroMRI [Time Frame: evolution over 12 months] [Designated as safety issue: No]
Time frame: evolution over 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Sanson, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectro-MRI, Dosage of free circulating plasmatic DNA and Dosage of D-2HG in the urine in people with Glioma and IDH1/IDH2 Mutation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Sanson, MD, PhD (+331 42 16 03 91, marc.sanson@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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] (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.