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Alopecia Areata Registry (NAAR)

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ClinicalTrials.gov Identifier: NCT00069589
Recruitment Status : Active, not recruiting
First Posted : September 30, 2003
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
National Alopecia Areata Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date September 29, 2003
First Posted Date September 30, 2003
Last Update Posted Date May 14, 2019
Study Start Date November 2001
Estimated Primary Completion Date November 2099   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2013)
Alopecia Areata Registry [ Time Frame: Registration on-going ]
Database registration of participants via collection of participant epidemiology data.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Alopecia Areata Registry
Official Title Alopecia Areata Registry and Immunogenetic Mechanisms
Brief Summary Alopecia areata is the loss of hair in patches that can proceed to loss of all hair (alopecia totalis or universalis). The purpose of the registry is to collect patient information and blood samples from people with alopecia areata.
Detailed Description

Alopecia areata is a condition in which hair is lost either from part of the scalp, all of the scalp, or the entire body, and it affects 1% to 2% of the population. It is thought to be an autoimmune disease and in some cases the disease is hereditary. The Alopecia Areata Registry will collect information and blood samples from clinically well-characterized patients with these three forms of alopecia areata: alopecia partialis (patchy loss of the scalp hair), alopecia totalis (total loss of all scalp hair), and alopecia universalis (complete loss of all hair everywhere on the body). This will be a collection of patients in multi-generational families, twins, single patients with patchy, persistent transient alopecia areata or long-standing alopecia totalis/universalis and with controls (persons unaffected and not related to alopecia patients). Information from these patients will be used to search the human genome for disease-associated loci and/or genes. Researchers interested in doing pathophysiology or treatment studies of this disease will also be able to contact patients having the appropriate form of the disease for the studies in question.

Patients who have been diagnosed with alopecia areata by a dermatologist will be eligible for the registry. Patients will fill out an information form online (alopeciaareataregistry.org). Patients who have a family history or specific types of alopecia will be invited to participate in a more detailed questionnaire and physical exam and have blood samples drawn.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA will be analyzed to learn the link between gene markers of traites of alopecia areata. Sera will be used to analyse cytokins. Lymphocytes will be used for the creation of B-cell lines.
Sampling Method Probability Sample
Study Population

Patients with alopecia areata (AA), both children and adults, who have been diagnosed by a physician with alopecia universalis, alopecia totalis, patchy persistent AA, or transient mild AA. Family members (related by blood) of these patients, preferably sib-pairs plus parents and multiplex families(persons with at least three family members with AA or alopecia universalis and alopecia totalis).

Also, healthy individuals who are unaffected, non-blood related individuals and do not live in the same household with alopecia areata patient are needed as controls.

Condition
  • Alopecia Areata
  • Alopecia Totalis
  • Alopecia Universalis
  • Autoimmune Hair Loss
  • Alopecia Partialis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 21, 2007)
3100
Original Enrollment
 (submitted: June 23, 2005)
2500
Estimated Study Completion Date November 2099
Estimated Primary Completion Date November 2099   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria

  • Diagnosed with alopecia areata by a dermatologist
  • United States resident

Accepts Health Volunteers: Non blood-related individuals who are unaffected with alopecia areata and do not live in the same household with alopecia areata patient.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00069589
Other Study ID Numbers NIAMS-097
HHSN268200682279C
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators National Alopecia Areata Foundation
Investigators
Principal Investigator: Madeleine Duvic, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019