Alopecia Areata Registry (NAAR)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 29, 2003 | ||||||||
| Last Updated Date | April 23, 2013 | ||||||||
| Start Date ICMJE | November 2001 | ||||||||
| Estimated Primary Completion Date | November 2099 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Alopecia Areata Registry [ Time Frame: Registration on-going ] [ Designated as safety issue: No ] Database registration of participants via collection of participant epidemiology data. |
||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00069589 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Alopecia Areata Registry | ||||||||
| Official Title ICMJE | 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 ICMJE | Observational | ||||||||
| Study Design ICMJE | 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 ICMJE |
|
||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | 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 ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 3100 | ||||||||
| Estimated Completion Date | November 2099 | ||||||||
| Estimated Primary Completion Date | November 2099 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria
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. |
||||||||
| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00069589 | ||||||||
| Other Study ID Numbers ICMJE | NIAMS-097, HHSN268200682279C | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | M.D. Anderson Cancer Center | ||||||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||||||
| Collaborators ICMJE | National Alopecia Areata Foundation | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | M.D. Anderson Cancer Center | ||||||||
| Verification Date | April 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||