Skin CancerNCT01820234
Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
A study testing In-person dermatology evaluation and Store-and-forward teledermatology evaluation in people with Skin Cancer and Screening, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer, Screening, Telemedicine
- What is being tested?
- In-person dermatology evaluation and Store-and-forward teledermatology evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who will not provide informed consent
- Patient who are unable to fulfill tasks of this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Shifa Community Clinic
Sacramento, California, 95818
About this study
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:
- Compared to in-person assessment, store-and-forward teledermatology assessment will result in adequate diagnostic concordance.
- Compared to in-person assessment, store-and-forward teledermatology results in adequate management concordance.
- 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.
- Conditions
- Skin Cancer, Screening, Telemedicine
- Being tested
- In-person dermatology evaluation, Store-and-forward teledermatology evaluation
- Keywords
- Skin cancer, Teledermatology, Screening, Store-and-forward
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person dermatology evaluationOther
Every patient will be evaluated by an in person dermatologist present at the screening.
Store-and-forward teledermatology evaluationOther
Also called Health care modality
Every patient will be evaluated online via a store and forward teledermatology modality.
| Study group | Role | What they receive |
|---|---|---|
| In-person dermatology evaluation | Other | Health care modality Receives: Other: In-person dermatology evaluation |
| Store-and-forward teledermatology evaluation | Other | Health care modality Receives: Other: Store-and-forward teledermatology evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of dermatologist evaluation (Day 1)
Secondary outcomes (5)
Primary diagnostic concordance
Diagnostic concordance between the in-person dermatologist and the teledermatologist for their primary diagnosis.
Measured: At the time of dermatologist evaluation (Day 1)
Categorical diagnostic concordance
Diagnostic concordance between the in-person dermatologist and teledermatologist based on standard clinical diagnostic categories for each lesion.
Measured: At the time of dermatologist evaluation (Day 1)
Management concordance
The concordance between the in-person dermatologist and teledermatologist for the chosen management plan for each lesion.
Measured: At the time of dermatologist evaluation (Day 1)
Sensitivity
The sensitivity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.
Measured: At the time of dermatologist evaluation (Day 1)
Specificity
The specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.
Measured: At the time of dermatologist evaluation (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- April W Armstrong, MD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820234
- Sponsor's protocol ID
- 201018315
- Status last verified
- Mar 2013
- First submitted
- 4 Feb 2011
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
- ClinicalTrials.gov ID
- NCT01820234
- Acronym / sponsor ID
- 201018315
- Conditions
- Skin Cancer, Screening, Telemedicine
- Keywords
- Skin cancer, Teledermatology, Screening, Store-and-forward
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compared to in-person assessment, store-and-forward teledermatology assessment will result in adequate diagnostic concordance.
- Compared to in-person assessment, store-and-forward teledermatology results in adequate management concordance.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person dermatology evaluation | Other | Other: In-person dermatology evaluationHealth care modality |
| Store-and-forward teledermatology evaluation | Other | Other: Store-and-forward teledermatology evaluationHealth care modality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who will not provide informed consent
- Patient who are unable to fulfill tasks of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person dermatology evaluationEvery patient will be evaluated by an in person dermatologist present at the screening. | Other | In-person dermatology evaluation |
| Store-and-forward teledermatology evaluationAlso: Health care modalityEvery patient will be evaluated online via a store and forward teledermatology modality. | Other | Store-and-forward teledermatology evaluation |
Primary outcome
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.
5 secondary outcomes
Primary diagnostic concordance
Time frame: At the time of dermatologist evaluation (Day 1)
Categorical diagnostic concordance
Time frame: At the time of dermatologist evaluation (Day 1)
Management concordance
Time frame: At the time of dermatologist evaluation (Day 1)
Sensitivity
Time frame: At the time of dermatologist evaluation (Day 1)
Specificity
Time frame: At the time of dermatologist evaluation (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
April W Armstrong, MD, MPH principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person dermatology evaluation and Store-and-forward teledermatology evaluation in people with Skin Cancer and Screening, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggregated diagnostic concordance (time frame: At the time of dermatologist evaluation (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.