Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT00710151
Status:
TERMINATED
Last Update Posted:
2017-04-21
First Post:
2008-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurotoxicity in Primary Central Nervous System Lymphoma (PCNSL): An International Observational Study of Cognition in Long Term Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2008-07-02', 'studyFirstSubmitQcDate': '2008-07-02', 'lastUpdatePostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropsychological Functioning', 'timeFrame': 'More than 2 years after treatment'}], 'secondaryOutcomes': [{'measure': 'MRI', 'timeFrame': 'More than 2 years after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neurotoxicity', 'cognition in survivors', 'diagnostic imaging'], 'conditions': ['Primary Central Nervous System Lymphoma (PCNSL)']}, 'descriptionModule': {'briefSummary': 'This research is being done to investigate cognition in long term survivors of Primary Central Nervous System Lymphoma (PCNSL). Sometimes caregivers as well as patients who no longer have the disease report cognitive problems such as reduced memory or attentional dysfunction and decreased quality of life. Unfortunately, little is known about what may contribute to this cognitive dysfunction in part because PCNSL is a rare disease and sensitive tests have not often been used in the research studies. This project is being conducted to help understand what factors, such as radiation, may contribute to cognitive dysfunction and better define the relationship between brain structure and thinking in people who have had PCNSL.', 'detailedDescription': "This is an international, multi-center project that will enroll as many as 118 subjects of which approximately 35 will be enrolled at Oregon Health \\& Science University (OHSU). Neuropsychological testing will consist of a battery of paper and pencil tests that examine abilities such as memory, motor skills, attention and speed of information processing. Questionnaires that assess quality of life will also be administered. These noninvasive tests are administered by a trained examiner or neuropsychologist and last about 30 minutes. Subjects will also undergo an MRI of the head which provides a picture of the brain's structure by placing an individual inside a powerful magnet. Statistical analyses will examine the relationship between the neuropsychological test scores and magnetic resonance (MR) images as well as examine the contribution of factors such as radiation, age, surgery, chemotherapy etc. to cognition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who have had PCNSL and have survived disease-free for 2 years or more.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radiological and histological diagnosis of PCNSL\n* Age 18 years or older\n* Survived 2 years or more following treatment\n* Able to complete neuropsychological and neuroimaging parts of the study\n* Signed a written informed consent in accordance with institutional guidelines\n\nExclusion Criteria:\n\n* Subject has experienced recurrent disease\n* Subject has a contraindication for MRI\n* Subject has a contraindication for neuropsychological testing\n* Subject has stage IV or V renal insufficiency'}, 'identificationModule': {'nctId': 'NCT00710151', 'briefTitle': 'Neurotoxicity in Primary Central Nervous System Lymphoma (PCNSL): An International Observational Study of Cognition in Long Term Survivors', 'nctIdAliases': ['NCT00706472'], 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Neurotoxicity in Primary Central Nervous System Lymphoma: An International, Collaborative, Observational Study of Cognition in Long-Term Survivors', 'orgStudyIdInfo': {'id': 'IRB00003805'}, 'secondaryIdInfos': [{'id': 'R01NS033618', 'link': 'https://reporter.nih.gov/quickSearch/R01NS033618', 'type': 'NIH'}, {'id': 'OHSU-3805', 'type': 'OTHER', 'domain': 'OHSU IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Subjects with PCNSL who have survived disease-free for 2 years or more. Treatments will vary depending upon site of enrollment and will include chemotherapy, blood brain barrier disruption (BBBD) with chemotherapy, radiation, and stem cell transplantation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite University Medicine', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'University of Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'University Medical Center', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Edward A Neuwelt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Edward Neuwelt', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}