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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01820234
Other study ID # 201018315
Secondary ID
Status Completed
Phase N/A
First received February 4, 2011
Last updated July 17, 2017
Start date September 2010
Est. completion date June 2011

Study information

Verified date March 2013
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
In-person dermatology evaluation
Every patient will be evaluated by an in person dermatologist present at the screening.
Store-and-forward teledermatology evaluation
Every patient will be evaluated online via a store and forward teledermatology modality.

Locations

Country Name City State
United States University of California, Davis Shifa Community Clinic Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

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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