Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
Study NCT ID:
NCT00313495
Status:
UNKNOWN
Last Update Posted:
2011-03-07
First Post:
2006-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cooperative Huntington's Observational Research Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, DNA and Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-04', 'studyFirstSubmitDate': '2006-04-10', 'studyFirstSubmitQcDate': '2006-04-10', 'lastUpdatePostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Huntington disease, observational, family members, biomarker'], 'conditions': ['Huntington Disease']}, 'referencesModule': {'references': [{'pmid': '31611263', 'type': 'DERIVED', 'citation': 'Connors MH, Teixeira-Pinto A, Loy CT. Psychosis and longitudinal outcomes in Huntington disease: the COHORT Study. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):15-20. doi: 10.1136/jnnp-2019-320646. Epub 2019 Oct 13.'}, {'pmid': '24126537', 'type': 'DERIVED', 'citation': 'Dorsey ER, Beck CA, Darwin K, Nichols P, Brocht AF, Biglan KM, Shoulson I; Huntington Study Group COHORT Investigators. Natural history of Huntington disease. JAMA Neurol. 2013 Dec;70(12):1520-30. doi: 10.1001/jamaneurol.2013.4408.'}, {'pmid': '22359536', 'type': 'DERIVED', 'citation': 'Huntington Study Group COHORT Investigators; Dorsey E. Characterization of a large group of individuals with huntington disease and their relatives enrolled in the COHORT study. PLoS One. 2012;7(2):e29522. doi: 10.1371/journal.pone.0029522. Epub 2012 Feb 16.'}], 'seeAlsoLinks': [{'url': 'http://www.Huntington-Study-Group.org', 'label': 'The Huntington Study Group (HSG) is a non-profit group of physicians and other health care providers from medical centers in the U.S., Canada, Europe and Australia, experienced in the care of Huntington patients and dedicated to clinical research of HD.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect prospective data from individuals who are part of a Huntington Disease (HD) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments for HD, and to plan for future research studies of experimental drugs aimed at slowing or postponing the onset and progression of HD.', 'detailedDescription': "COHORT (Cooperative Huntington Observational Research Trial) is a coordinated research effort by Huntington Study Group research centers worldwide to prospectively collect data from consenting individuals who are affected by Huntington's disease (HD) and who are part of an HD family. The systematically accrued data from annual prospective assessments will relate clinical characteristics (phenotypes) between families with genetic and environmental factors. The knowledge from these relationships will better inform us about the onset and progression of HD, help identify potential interventions for HD, and aid in planning research studies of experimental treatments aimed at slowing or postponing the onset of HD. The consented collection of biological samples will further provide research material and correlative data for scientists to identify biomarkers that parallel the development and progression of HD. Identification of biomarkers will in turn contribute to our understanding of HD and enhance the efficiency and power of disease-modifying therapeutic trials."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "1. An individual of any age that is affected by Huntington's disease\n2. An individual 18 years of age or older, who has tested positive for the HD gene\n3. An individual 18 years of age or older who is a parent, sibling or child of an individual affected by HD\n4. An older adolescent 15 to 17 years of age, who has a parent affected by HD enrolled in COHORT, or a parent who has tested positive for the HD gene enrolled in COHORT (at select sites)\n5. Grandparents and grandchildren of anyone participating in COHORT who fulfills the requirements of (the above) category (1) or (2)\n6. HD family members who have no risk for HD due to no family history (spouses or caregivers)\n7. HD family members who have undergone DNA testing and does not carry the genetic mutation responsible for HD.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) MANIFEST/PRE-MANIFEST HD: Individuals of any age who are affected by HD OR an individual 18 years or older who - has tested positive for the HD gene.\n* (2) INDIVIDUALS AT RISK: An individual 18 years or older who has not undergone DNA testing for the mutation responsible for HD and who is a first degree relative (parent, sibling, child) of an individual with Manifest or pre-manifest HD OR an older adolescent 15 to 17 years of age who has a parent with manifest HD or pre-manifest HD enrolled in COHORT.\n* (3) ADULTS AT SECONDARY RISK: An individual 18 years of age or older who has not undergone DNA testing for the mutation responsible for HD and is a grandparent or grandchild of an individual enrolled in COHORT who has manifest HD or pre-manifest HD\n* (4) CONTROL: A spouse or caregiver, 18 years of age or older, of an individual enrolled in COHORT who has manifest HD or pre-manifest HD\n* (5) ADULT GENE NEGATIVE: An individual, 18 years of age or older, with a family history of HD who has undergone DNA testing and does not carry the genetic mutation responsible for HD.\n\nExclusion Criteria:\n\n* (1) Anyone who does not fit the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00313495', 'briefTitle': "Cooperative Huntington's Observational Research Trial", 'organization': {'class': 'OTHER', 'fullName': 'HP Therapeutics Foundation'}, 'officialTitle': "Cooperative Huntington's Observational Research Trial", 'orgStudyIdInfo': {'id': 'COHORT'}}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angeline Gratiano', 'role': 'CONTACT', 'email': 'agratiano@mednet.ucla.edu', 'phone': '310-206-2154'}], 'facility': 'UCLA School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Mans', 'role': 'CONTACT', 'email': 'nicole.mans@ucdmc.ucdavis.edu', 'phone': '916-734-3541'}], 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'jody goldstein', 'role': 'CONTACT', 'email': 'jlgoldstein@ucsd.edu', 'phone': '858-622-5854'}], 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Gooblar, BA', 'role': 'CONTACT', 'email': 'jgooblar@memory.ucsf.edu', 'phone': '415-476-1686'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Littleton', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diane Erickson', 'role': 'CONTACT', 'email': 'derickson@thecni.org', 'phone': '303-762-6674'}], 'facility': 'Colorado Neurological Institute', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Jane Fitzpatrick', 'role': 'CONTACT', 'email': 'fitzpatrick@psychiatry.uchc.edu', 'phone': '860-679-4441'}], 'facility': 'University of Connecticut', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Candace Cotto', 'role': 'CONTACT', 'email': 'ccotto@indd.org', 'phone': '203-401-4339'}], 'facility': 'Institutue for Neurodegenerative Disorders', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Monica Quesada', 'role': 'CONTACT', 'email': 'mquesada2@med.miami.edu', 'phone': '305-243-3647'}], 'facility': 'University of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marcia McCall', 'role': 'CONTACT', 'email': 'mamccall@hsc.usf.edu', 'phone': '813-974-6022'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elaine Sperin', 'role': 'CONTACT', 'email': 'esperin@emory.edu', 'phone': '404-728-4786'}], 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Buff Farrow', 'role': 'CONTACT', 'email': 'bfarrow@georgiahealth.edu', 'phone': '706-721-0619'}], 'facility': 'Medical College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeana Jaglin', 'role': 'CONTACT', 'email': 'jjaglin2@rush.edu', 'phone': '312-942-5003'}], 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joan Young', 'role': 'CONTACT', 'email': 'jyoung@neurology.bsd.uchicago.edu', 'phone': '773-702-4392'}], 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': 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'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Greg Suter', 'role': 'CONTACT', 'email': 'hndcentre@aol.com', 'phone': '316-721-9250'}], 'facility': 'Hereditary Neurological Disease Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40294', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Annette Robinson', 'role': 'CONTACT', 'email': 'annette.robinson@louisville.edu', 'phone': '502-540-3585'}], 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Claire Welsh', 'role': 'CONTACT', 'email': 'cswelsh@jhmi.edu', 'phone': '410-955-1349'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Doyle', 'role': 'CONTACT', 'email': 'ldoyle@upi.umaryland.edu', 'phone': '410-328-3339'}], 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Diggin', 'role': 'CONTACT', 'email': 'melissa.diggin@bmc.org', 'phone': '617-638-7704'}], 'facility': 'Boston University School of Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert McInnis', 'role': 'CONTACT', 'email': 'rmcinnis@partners.org', 'phone': '617-723-5694'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': 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'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Chesire', 'role': 'CONTACT', 'email': 'amy.chesire@ctcc.rochester.edu', 'phone': '585-341-7519'}], 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Wyne', 'role': 'CONTACT', 'email': 'wyne1991@duke.edu', 'phone': '919-668-2837'}], 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Christine O'Neill", 'role': 'CONTACT', 'email': 'coneil@iupui.edu', 'phone': '336-716-8611'}], 'facility': 'Wake Forest University Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Beth Bialick', 'role': 'CONTACT', 'email': 'howardb33@aol.com', 'phone': '513-558-0018'}], 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Reece', 'role': 'CONTACT', 'email': 'houser@ccf.org', 'phone': '216-445-9833'}], 'facility': 'The Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allison Seward', 'role': 'CONTACT', 'email': 'allison.seward@osumc.edu', 'phone': '614-688-8672'}], 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Iman Affan', 'role': 'CONTACT', 'email': 'iman.affan@uphs.upenn.edu', 'phone': '215-829-3582'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Lucarelli', 'role': 'CONTACT', 'email': 'lucarellina2@upmc.edu', 'phone': '412-692-4659'}], 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nathan Jones', 'role': 'CONTACT', 'email': 'njones37@utmem.edu', 'phone': '901-448-6180'}], 'facility': 'University of Tennessee-Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Giselle Huet, MS', 'role': 'CONTACT', 'email': 'giselle.huet@utsouthwestern.edu', 'phone': '214-648-0378'}, {'name': 'Amit Gode, MPH', 'role': 'CONTACT', 'email': 'amit.gode@utsouthwestern.edu', 'phone': '214-648-0417'}], 'facility': 'Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tiffany Reedus', 'role': 'CONTACT', 'email': 'treedus@bcm.edu', 'phone': '713-798-7438'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paola Wall', 'role': 'CONTACT', 'email': 'paola.wall@hsc.utah.edu', 'phone': '801-581-4543'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Davis', 'role': 'CONTACT', 'email': 'rbd4n@virginia.edu', 'phone': '434-243-5692'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marsha Merrick', 'role': 'CONTACT', 'email': 'mgmerrick@evergreenhealthcare.org', 'phone': '425-899-3115'}], 'facility': 'Booth Gardner Parkinsons Center', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'city': 'Wentworthville', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Jane Griffith', 'role': 'CONTACT', 'email': 'jane_griffith@wsahs.nsw.gov.au', 'phone': '011-61-2-98456793'}], 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80652, 'lon': 150.96785}}, {'city': 'Kew', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Bernadette Mannaa', 'role': 'CONTACT', 'email': 'bmannaa@unimelb.edu.au', 'phone': '61 3 9816 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