Cooperative Huntington's Observational Research Trial

NCT ID: NCT00313495

Last Updated: 2011-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Huntington Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* (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.
* (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.
* (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
* (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
* (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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huntington Study Group

NETWORK

Sponsor Role collaborator

HP Therapeutics Foundation

OTHER

Sponsor Role lead

Responsible Party

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University of Rochester

Principal Investigators

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Ira Shoulson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester/Huntington Study Group

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status TERMINATED

UCLA School of Medicine

Los Angeles, California, United States

Site Status RECRUITING

University of California, Davis

Sacramento, California, United States

Site Status RECRUITING

University of California, San Diego

San Diego, California, United States

Site Status RECRUITING

University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Colorado Neurological Institute

Littleton, Colorado, United States

Site Status RECRUITING

University of Connecticut

Hartford, Connecticut, United States

Site Status RECRUITING

Institutue for Neurodegenerative Disorders

New Haven, Connecticut, United States

Site Status RECRUITING

University of Miami School of Medicine

Miami, Florida, United States

Site Status RECRUITING

University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Medical College of Georgia

Augusta, Georgia, United States

Site Status RECRUITING

Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status RECRUITING

University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Hereditary Neurological Disease Center

Wichita, Kansas, United States

Site Status RECRUITING

University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

University of Maryland

Baltimore, Maryland, United States

Site Status RECRUITING

Boston University School of Medicine

Boston, Massachusetts, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status ACTIVE_NOT_RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Albany Medical College

Albany, New York, United States

Site Status RECRUITING

Columbia University

New York, New York, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

The Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

University of Tennessee-Memphis

Memphis, Tennessee, United States

Site Status RECRUITING

Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Baylor College of Medicine

Houston, Texas, United States

Site Status RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Booth Gardner Parkinsons Center

Kirkland, Washington, United States

Site Status RECRUITING

Westmead Hospital

Wentworthville, New South Wales, Australia

Site Status RECRUITING

The University of Melbourne

Kew, Victoria, Australia

Site Status RECRUITING

Graylands, Selby-Lemnos & Special Care Health Services

Perth, Western Australia, Australia

Site Status RECRUITING

University of Calgary Medical Clinic

Calgary, Alberta, Canada

Site Status RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

Site Status RECRUITING

Movement Disorder Clinic Deer Lodge Centre

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Movement Disorders Clinic, Deer Lodge Centre

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Halifax Infirmary

Halifax, Nova Scotia, Canada

Site Status RECRUITING

London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

The Centre for Addiction and Mental Health

Markham, Ontario, Canada

Site Status RECRUITING

Hotel-Dieu Hospital-CHUM

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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United States Australia Canada

Central Contacts

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Huntington Study Group

Role: CONTACT

800-487-7671

Facility Contacts

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Angeline Gratiano

Role: primary

310-206-2154

Nicole Mans

Role: primary

916-734-3541

jody goldstein

Role: primary

858-622-5854

Jonathan Gooblar, BA

Role: primary

415-476-1686

Diane Erickson

Role: primary

303-762-6674

Mary Jane Fitzpatrick

Role: primary

860-679-4441

Candace Cotto

Role: primary

203-401-4339

Monica Quesada

Role: primary

305-243-3647

Marcia McCall

Role: primary

813-974-6022

Elaine Sperin

Role: primary

404-728-4786

Buff Farrow

Role: primary

706-721-0619

Jeana Jaglin

Role: primary

312-942-5003

Joan Young

Role: primary

773-702-4392

Melissa Wesson

Role: primary

317-274-2390

Michelle Harreld

Role: primary

319-384-1174

Hillary Dubinsky

Role: primary

913-945-5019

Greg Suter

Role: primary

316-721-9250

Annette Robinson

Role: primary

502-540-3585

Claire Welsh

Role: primary

410-955-1349

Lauren Doyle

Role: primary

410-328-3339

Melissa Diggin

Role: primary

617-638-7704

Robert McInnis

Role: primary

617-723-5694

Stacey Barton

Role: primary

314-362-3471

Sharon Evans

Role: primary

518-262-6611

Ronda Clouse

Role: primary

212-305-2387

Amy Chesire

Role: primary

585-341-7519

Sarah Wyne

Role: primary

919-668-2837

Christine O'Neill

Role: primary

336-716-8611

Mary Beth Bialick

Role: primary

513-558-0018

Christine Reece

Role: primary

216-445-9833

Allison Seward

Role: primary

614-688-8672

Iman Affan

Role: primary

215-829-3582

Nancy Lucarelli

Role: primary

412-692-4659

Nathan Jones

Role: primary

901-448-6180

Giselle Huet, MS

Role: primary

214-648-0378

Amit Gode, MPH

Role: backup

214-648-0417

Tiffany Reedus

Role: primary

713-798-7438

Paola Wall

Role: primary

801-581-4543

Robert Davis

Role: primary

434-243-5692

Marsha Merrick

Role: primary

425-899-3115

Jane Griffith

Role: primary

011-61-2-98456793

Bernadette Mannaa

Role: primary

61 3 9816 0444 ext. 8114

Steve Andrew

Role: primary

618 9347 6464

Mary Lou Klimek

Role: primary

403-210-8548

Allison Coleman

Role: primary

604-822-7739

Sandra Funk

Role: primary

204-940-8547

Sandra Funk

Role: primary

204-940-8547

Joanne Courtney-Walker

Role: primary

902-473-8261

Emilija Makaji, MSC

Role: primary

519-685-8500 ext. 36893

Irita Karmalkar

Role: primary

905-472-7082 ext. 229

Suzanne Paris

Role: primary

514-890-8000 ext. 26511

References

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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.

Reference Type DERIVED
PMID: 31611263 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24126537 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22359536 (View on PubMed)

Other Identifiers

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COHORT

Identifier Type: -

Identifier Source: org_study_id

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