Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-28 @ 11:51 PM
Study NCT ID:
NCT06817395
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impairment of fluid cognition', 'timeFrame': 'Baseline', 'description': 'Proportion of subjects with mild (T-score 1 to 2 standard deviations \\[SDs\\] below the normative mean) or major (\\>2 SDs below the normative mean) impairment of the composite measure of fluid cognition, as detected on the NIH Toolbox cognition battery.'}], 'secondaryOutcomes': [{'measure': 'Feasibility of longitudinal assessments', 'timeFrame': '2 years', 'description': 'Completion of annual study visit by at least 50% of the enrolled study population over course of 2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive impairment', 'Immune thrombocytopenia', 'ITP', 'Quality of life', 'Cognitive dysfunction', 'Cognition'], 'conditions': ['Immune Thrombocytopenia']}, 'referencesModule': {'references': [{'pmid': '22044734', 'type': 'BACKGROUND', 'citation': 'Frith J, Watson S, Bolton Maggs PH, Newton JL. Cognitive symptoms are common in immune thrombocytopenia and associate with autonomic symptom burden. Eur J Haematol. 2012 Mar;88(3):224-8. doi: 10.1111/j.1600-0609.2011.01730.x. Epub 2011 Dec 12.'}, {'pmid': '31119732', 'type': 'BACKGROUND', 'citation': 'Mitchell E, Frith J, Newton J. Fatigue and cognitive impairment in immune thrombocytopenic purpura remain stable over time: short report from a longitudinal study. Br J Haematol. 2019 Sep;186(5):777-781. doi: 10.1111/bjh.15993. Epub 2019 May 23.'}, {'pmid': '38724473', 'type': 'BACKGROUND', 'citation': 'Kuter DJ, Khan U, Maruff P, Daak A. Cognitive impairment among patients with chronic immune thrombocytopenia. Br J Haematol. 2024 Jul;205(1):291-299. doi: 10.1111/bjh.19495. Epub 2024 May 9.'}]}, 'descriptionModule': {'briefSummary': 'Individuals with immune thrombocytopenia (ITP) frequently report difficulties with attention and memory. The main question this study seeks to answer is:\n\nDo patients with ITP have evidence of cognitive impairment as detected by a cognitive function test battery?\n\nTo address this issue, participants will take a cognitive function test and complete surveys on quality of life, fatigue, depression, and cognitive symptoms. The primary aim of the study is to evaluate for the presence and extent of cognitive impairment in patients with ITP. The study will also assess whether cognitive impairment in ITP is associated with patient-reported impacts on quality of life, fatigue, mood, and cognitive symptoms as well as clinical characteristics such as ITP disease and treatment history.', 'detailedDescription': 'This is a longitudinal observational study that seeks to evaluate for the prevalence and extent of cognitive dysfunction in adults with persistent and chronic ITP. Following enrollment, subjects will complete neurocognitive testing using the NIH Toolbox Cognition Battery (NIHTB-CB). In addition, subjects will complete surveys for patient-reported outcomes of quality of life, fatigue, self-reported cognitive function, and depression. Background characteristics and relevant clinical history will be obtained through an enrollment survey and chart review. The primary aim of the study is to describe the prevalence and extent of cognitive impairment in ITP and explore associated risk factors. This study will also assess the feasibility of longitudinal cognitive testing in patients with ITP and describe any observed changes in cognition over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a history of chronic or persistent ITP without pre-existing diagnosis of cognitive impairment will be recruited from the outpatient non-malignant hematology clinic at Massachusetts General Hospital (MGH).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥ 18 years\n* A clinical diagnosis of persistent or chronic ITP, as defined by a history of platelet counts \\<50 x 109/L on two occasions in the preceding 3 to 12 months or \\>12 months, respectively, and documented response to at least 1 prior ITP-directed therapy. ITP-directed therapies include corticosteroids, intravenous immune globulin, Rho(D) immune globulin, splenectomy, thrombopoietin receptor agonists, and fostamatinib. Other qualifying agents used for the treatment of ITP are permissible with approval of the principal investigator.\n* Ability to follow instructions in English.\n\nExclusion Criteria:\n\n* Pre-existing diagnosis of cognitive impairment from dementia, stroke, or other neurologic disease.\n* Active psychiatric disorder, defined as uncontrolled major depression, schizophrenia, severe anxiety, or active alcohol or drug abuse.\n* Active malignancy, requiring or likely to require chemotherapeutic or surgical treatment, except for non-melanoma skin cancer.\n* Brain tumor or cranial surgery within the past year.\n* Significant hearing or vision impairment that would preclude the ability to complete neurocognitive testing via a virtual platform.'}, 'identificationModule': {'nctId': 'NCT06817395', 'acronym': 'COGFIT', 'briefTitle': 'Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Prevalence, Reproducibility, and Feasibility of Longitudinal Assessment of Neurocognitive Dysfunction in Adults with Chronic and Persistent Immune Thrombocytopenia (COGFIT)', 'orgStudyIdInfo': {'id': '2024P000181'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with chronic or persistent ITP'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie C Jiang, MD', 'role': 'CONTACT', 'email': 'dcjiang@mgh.harvard.edu', 'phone': '617-724-4000'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Debbie Jiang, MD', 'role': 'CONTACT', 'email': 'dcjiang@mgh.harvard.edu', 'phone': '617-724-4000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Mass General Brigham encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Platelet Disorder Support Association (PDSA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Debbie Jiang, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}