Questionnaire and Laboratory Data on Vitiligo Vulgaris
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| First Received Date ICMJE | September 20, 2010 | ||||||||
| Last Updated Date | July 21, 2011 | ||||||||
| Start Date ICMJE | August 2010 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01206374 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 | Questionnaire and Laboratory Data on Vitiligo Vulgaris | ||||||||
| Official Title ICMJE | Demographic and Laboratory Data Collection for Patients With Vitiligo Vulgaris | ||||||||
| Brief Summary | Vitiligo vulgaris is an autoimmune disorder that causes loss of pigmentation over the skin, hair and mucous membranes (e.g. lips, nose, genitals). While genes have been identified that are thought to be required for development of vitiligo, only 5-10% of relatives develop disease. The triggers for disease onset have not yet been identified. The intent of this study is to research trends in laboratory data, social and medical history that may be contributory to vitiligo onset, location of disease, course of illness and response to therapy. |
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| Detailed Description | Patients who participate in this study will be asked to complete a survey and have blood/ laboratory testing performed that relates or may relate to the diagnosis of vitiligo. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | All patients willing to sign consent, complete questionnaire and/ or laboratory studies. |
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| Condition ICMJE | Vitiligo Vulgaris | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | August 2013 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01206374 | ||||||||
| Other Study ID Numbers ICMJE | 10-027SLRHC | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Nanette B. Silverberg, MD, Department of Dermatology, St. Luke's-Roosevelt Hospital Center | ||||||||
| Study Sponsor ICMJE | St. Luke's-Roosevelt Hospital Center | ||||||||
| Collaborators ICMJE | Beth Israel Medical Center | ||||||||
| Investigators ICMJE |
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| Information Provided By | St. Luke's-Roosevelt Hospital Center | ||||||||
| Verification Date | July 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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