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OpenTrials
Completed

NCT Number: NCT01820234

Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis Shifa Community Clinic

Sacramento, California, 95818, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-person dermatology evaluation

Other

Every patient will be evaluated by an in person dermatologist present at the screening.

Store-and-forward teledermatology evaluation

Other

Every patient will be evaluated online via a store and forward teledermatology modality.

Other names: Health care modality

Primary outcomes

  1. Aggregated diagnostic concordance

    Time frame: At the time of dermatologist evaluation (Day 1)

    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.

Secondary outcomes

  1. Primary diagnostic concordance

    Time frame: At the time of dermatologist evaluation (Day 1)

    Diagnostic concordance between the in-person dermatologist and the teledermatologist for their primary diagnosis.

  2. Categorical diagnostic concordance

    Time frame: At the time of dermatologist evaluation (Day 1)

    Diagnostic concordance between the in-person dermatologist and teledermatologist based on standard clinical diagnostic categories for each lesion.

  3. Management concordance

    Time frame: At the time of dermatologist evaluation (Day 1)

    The concordance between the in-person dermatologist and teledermatologist for the chosen management plan for each lesion.

  4. Sensitivity

    Time frame: At the time of dermatologist evaluation (Day 1)

    The sensitivity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.

  5. Specificity

    Time frame: At the time of dermatologist evaluation (Day 1)

    The specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 28, 2013
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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