Skin Cancer Clinical Trial
Official title:
Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
Verified date | March 2013 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the diagnostic and management concordance of
face-to-face dermatologist versus a store-and-forward teledermatologist at a skin cancer
screening event.
The investigators' hypotheses include the following:
1. Compared to in-person assessment, store-and-forward teledermatology assessment will
result in adequate diagnostic concordance.
2. Compared to in-person assessment, store-and-forward teledermatology results in adequate
management concordance.
3. The sensitivity and specificity of store-and-forward evaluation to detecting lesions
that are either premalignant or malignant will be similar to that of in-person
evaluation.
Status | Completed |
Enrollment | 170 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age or older at time of consent, may be male or female. - Able to provide a brief medical history and have/allow an examination of their skin including photographs. - Capable of giving informed consent. - Will be able to receive notification of follow-up recommendations Exclusion Criteria: - Patients who will not provide informed consent - Patient who are unable to fulfill tasks of this study |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Davis Shifa Community Clinic | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aggregated diagnostic concordance | Aggregated diagnostic concordance which is defined as the agreement of the in-person dermatologist's principle diagnosis with the teledermatologist's primary diagnosis or any of the differential diagnoses. | At the time of dermatologist evaluation (Day 1) | |
Secondary | Primary diagnostic concordance | Diagnostic concordance between the in-person dermatologist and the teledermatologist for their primary diagnosis. | At the time of dermatologist evaluation (Day 1) | |
Secondary | Categorical diagnostic concordance | Diagnostic concordance between the in-person dermatologist and teledermatologist based on standard clinical diagnostic categories for each lesion. | At the time of dermatologist evaluation (Day 1) | |
Secondary | Management concordance | The concordance between the in-person dermatologist and teledermatologist for the chosen management plan for each lesion. | At the time of dermatologist evaluation (Day 1) | |
Secondary | Sensitivity | The sensitivity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant. | At the time of dermatologist evaluation (Day 1) | |
Secondary | Specificity | The specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant. | At the time of dermatologist evaluation (Day 1) |
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