Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT02597335
Status:
UNKNOWN
Last Update Posted:
2017-09-20
First Post:
2015-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non Invasive Detection of IDH1/2 Mutation in Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-19', 'studyFirstSubmitDate': '2015-04-27', 'studyFirstSubmitQcDate': '2015-11-03', 'lastUpdatePostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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]', 'timeFrame': '3 months after surgery', 'description': 'This ratio D-2HG/creatine will be correlated with the dosage obtained in tumor tissue performed within three months after the surgery'}], 'secondaryOutcomes': [{'measure': 'SpectroMRI [Time Frame: evolution over 12 months] [Designated as safety issue: No]', 'timeFrame': 'evolution over 12 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glioma', 'IDH1/IDH2 mutation', 'Spectroscopy MRI', 'D-2-hydroxyglutarate', 'Free circulating DNA'], 'conditions': ['Glioma', 'IDH1/IDH2 Mutation']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nIn 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.', 'detailedDescription': '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.\n\nThe 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).\n\nThe secondary endpoints include:\n\n1. longitudinal analysis Spectro-MRI overtime (12 months) correlation with radiological evolution and the response to treatment (group 2: 15 patients)\n2. Differentiation of tumor recurrence from radiation induced changes\n3. Confrontation of Spectro-MRI, D-2HG dosages and IDH mutation detection from plasma DNA, and elaboration of a combined score of prediction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Affiliation to a social security system\n2. Patient≥ 18 years old\n3. Written informed consent\n4. One of the two situations:\n\n * presumed grade II-III glioma candidate to surgery (group 1)\n * IDH1/IDH2 mutated grade II-III gliomas, candidate to chemotherapy or radiotherapy treatment, or simple follow-up (group 2)\n5. Evaluable tumoral mass min diameter \\>2 cm (FLAIR)\n6. PKPS \\> 60\n\nExclusion criteria\n\n1. Contra-indication to MRI\n2. Patient unable to give an written Informed Consent\n3. Patient under guardianship or deprived of freedom\n4. For group 2: patient already included in group 1'}, 'identificationModule': {'nctId': 'NCT02597335', 'acronym': 'IDASPE', 'briefTitle': 'Non Invasive Detection of IDH1/2 Mutation in Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'P120141'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDH1/IDH2', 'interventionNames': ['Radiation: Spectro-MRI', 'Other: Dosage of free circulating plasmatic DNA', 'Other: Dosage of D-2HG in the urine']}], 'interventions': [{'name': 'Spectro-MRI', 'type': 'RADIATION', 'description': 'Spectro-MRI for D-2HG detection', 'armGroupLabels': ['IDH1/IDH2']}, {'name': 'Dosage of free circulating plasmatic DNA', 'type': 'OTHER', 'armGroupLabels': ['IDH1/IDH2']}, {'name': 'Dosage of D-2HG in the urine', 'type': 'OTHER', 'armGroupLabels': ['IDH1/IDH2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc Sanson, MD, PhD', 'role': 'CONTACT', 'phone': '+331 42 16 03 91'}], 'facility': 'Groupe Hospitalier Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Marc Sanson, MD, PhD', 'role': 'CONTACT', 'email': 'marc.sanson@psl.aphp.fr', 'phone': '+331 42 16 03 91'}], 'overallOfficials': [{'name': 'Marc Sanson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}