Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-24 @ 10:35 AM
Study NCT ID:
NCT02791360
Status:
COMPLETED
Last Update Posted:
2018-01-26
First Post:
2016-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-25', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-06-03', 'lastUpdatePostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patient with MRI abnormality', 'timeFrame': 'up to 4 weeks', 'description': 'To evaluate the proportion of patients with at least one abnormality on an imaging test'}], 'secondaryOutcomes': [{'measure': 'MRI diffusion abnormality', 'timeFrame': 'up to 4 weeks'}, {'measure': 'MRI perfusion abnormality', 'timeFrame': 'up to 4 weeks'}, {'measure': 'MRI vascular morphologic abnormalities', 'timeFrame': 'up to 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Brain', 'Radiotherapy', 'MRI', 'Sequelae'], 'conditions': ['Brain Neoplasms']}, 'descriptionModule': {'briefSummary': 'Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nIn the case group:\n\n* A history of solid brain tumor or haematological histologically proven.\n* Patients previously treated with radiotherapy in this brain tumor (greater than or equal to 36 Gy dose).\n* Radiotherapy treatment on a tumor in place or operated.\n* Decline at least 10 years from the end of radiotherapy.\n* Treatment with isocentric conformal radiotherapy.\n* No other radiation therapy for locally recurrent brain metastases or new brain tumor.\n* Lack of known brain metastases or meningeal carcinomatosis.\n\nFor the control group:\n\n* Patients previously treated for cancer and disease relapse free for 10 years.\n* No brain radiotherapy treatment.\n* Lack of treatment with anti-cancer chemotherapy.\n* Women of childbearing potential must be under effective contraception.\n* Pairing according to age, sex, arms director and socio-cultural level.\n\nFor two groups:\n\n* Man or woman aged (e) of minimum 18 years.\n* Topic fluent French and comprising well.\n* Free and Informed Consent signed.\n* The subject should be affiliated to an appropriate social security system\n* No cons-indication to MRI.\n* The subject must have at least one primary school level\n\nExclusion Criteria:\n\nIn the case group:\n\n* Brain radiotherapy carried out by intensity modulation technique.\n* Radiation dose less than 36 Gy on the brain.\n* Subject with against-indication to MRI.\n\nFor the control group:\n\n* Previous history of brain radiotherapy.\n* Previous history of brain surgery.\n* Central neurological disorders, such as seizures, uncontrolled.\n\nFor two groups:\n\n* Current Topics in oral chemotherapy or intravenous.\n* Subject pregnant.\n* Subject is not fluent in French or including bad.\n* Any geographical conditions, social or associated psychopathology that could compromise the patient's ability to participate in the study.\n* Participation in a therapeutic trial for less than 30 days.\n* A person not affiliated with a social security scheme."}, 'identificationModule': {'nctId': 'NCT02791360', 'acronym': 'TCSEQ', 'briefTitle': 'Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor', 'orgStudyIdInfo': {'id': 'TCSEQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MRI evaluation', 'description': 'Patient pretreated for brain tumor and witness', 'interventionNames': ['Other: Brain MRI']}], 'interventions': [{'name': 'Brain MRI', 'type': 'OTHER', 'armGroupLabels': ['MRI evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14400', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}