Assessment of Digital Imaging as a Tool for Diagnosing Psoriasis, Hand Rashes and Unusual Moles
|First Received Date ICMJE||June 3, 2000|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||May 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005781 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|
|Brief Title ICMJE||Assessment of Digital Imaging as a Tool for Diagnosing Psoriasis, Hand Rashes and Unusual Moles|
|Official Title ICMJE||Digital Imaging as a Tool for Assessing the Prevalence of Atypical Nevi, Psoriasis and Hand Dermatitis: A Validation Study in Preparation for NHANES IV, Dermatology Section|
This study will evaluate whether digital photography is a reliable tool for diagnosing hand rashes, psoriasis and unusual moles. The findings will help determine if this method can be used in the National Health and Nutrition Examination survey (NHANES), which monitors disease in the United States.
Employees of the National Institutes of Health 19 years and older may enroll in this study. Participants will complete a brief questionnaire that includes information on skin type, history of skin conditions (moles, cancer, rashes, psoriasis), and demographic information such as name, age and sex. They will be examined by a dermatologist, who will note in writing the appearance of any hand rashes, unusual moles, or psoriasis. If any areas suspicious for skin cancer are found, the participant will receive this information in writing, along with advice about where to go for treatment.
A total of six photographs will then be taken of the participant's arms, legs, hands and back. The face will not be photographed, and the participants will not be identifiable.
This validation study is designed to evaluate the sensitivity, specificity, validity and reliability of digital photography of the skin as a prevalence assessment tool in preparation for the National Health and Nutrition Examination Survey, 2001 (NHANES IV). NHANES is charged with monitoring disease in the U.S. population, which is affected frequently by skin disorders and disease. The three skin disorders proposed for study in NHANES IV are atypical nevi, psoriasis, and hand dermatitis. This selection is based on the expected impact of these diseases on the U.S. population, including a prevalence of 3-10%, associated risk of melanoma in the case of atypical nevi, and associated disability in the cases of psoriasis and hand dermatitis.
This skin disease section of NHANES, as currently planned for 2001, includes an imaging component with four standardized photographs to be obtained from each survey participant (SP). The selection of the regions to be photographed is designed to maximize the information obtained, while preserving patient privacy and is based on the known distribution of clinical findings of the three conditions, as well as NHANES logistical limitations. This validation study is a cooperative effort between the NIAMS extramural programs, the NCI intramural program, and the National Center for Health Statistics.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||September 2000|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Must have employee status at the National Institutes of Health.
Age greater than 18 years.
Able to understand and sign consent.
Patients who are wheelchair bound and are unable to have images of their back and lower extremities taken safely will be excluded from photography since this portion of the examination requires an ability to stand. However, they will still be eligible to participate in the skin cancer screening.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00005781|
|Other Study ID Numbers ICMJE||000138, 00-C-0138|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2000|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP