Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 537 for:    "Skin cancer"

Utility of Digital Dermoscopy in the Skin Cancer Clinic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03497455
Recruitment Status : Active, not recruiting
First Posted : April 13, 2018
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Barco NV

Brief Summary:

This feasibility study aims to evaluate the use of the BARCO NV digital dermatoscope (non-CE marked device) in the skin cancer clinic. All eligible patients attending the Dermatology outpatient skin cancer clinic will be invited to participate. Patients who consent to the study will undergo standard care which will include medical photography of skin lesion(s) and appropriate management as determined by the Consultant Dermatologist in clinic. In addition to standard care, patients will undergo photography of the same lesion(s) using the BARCO NV digital dermatoscope. There will be no other intervention and no additional hospital visits in relation to the study. Use of the device will not influence the clinical management of the patient.

A detailed experience questionnaire will be administered to all clinicians using the BARCO device to explore their opinion on its ease of use and features.

All standard macroscopic & dermoscopic images will be taken by OUH medical illustration department and stored on the 'Fotoweb' database (in keeping with current standard practice). Trained Dermatology Consultants, Dermatology Registrars, Research nurses or Medical Photographers, will take BARCO NV device images. A database of all BARCO images will be collected and stored on a dedicated NHS computer separate from the patient clinical record. Standard medical photography images will be stored on Fotoweb as per standard NHS clinical care.

Data will be anonymised and collated and then sent securely to BARCO for further analyses to enable optimization of the BARCO device and for development of diagnostic algorithms in the future.


Condition or disease Intervention/treatment
Skin Cancer Dermatology/Skin - Other Device: Barco NV Digital Dermatoscope device images Device: Standard medical photographs including dermoscopy images Other: Clinic proforma completion

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Feasibility Study to Evaluate Utility of the BARCO NV Digital Dermatoscope in the Skin Cancer Clinic
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer


Intervention Details:
  • Device: Barco NV Digital Dermatoscope device images
    Images taken by Clinician in consultation OR in Dermatology department theatres OR images taken in medical photography suite - in the latter case, images can be taken by medical photographer or Research nurse or Dermatologist
  • Device: Standard medical photographs including dermoscopy images
    Images taken by medical photographer as part of standard care in the medical photography suite.
  • Other: Clinic proforma completion
    This is part of standard care and will be undertaken by the clinician who is responsible for the patient


Primary Outcome Measures :
  1. Clinician experience questionnaire results [ Time Frame: 1 year ]
    To assess the acceptability of the new dermoscope in the skin cancer clinic, questions about the usability of the device and about the image quality of the obtained dermoscopic pictures are included.


Secondary Outcome Measures :
  1. Collection of image database [ Time Frame: 1 year ]
    Anonymised database of clinicopathological and digital images of benign, malignant and equivocal skin lesions + Proportion of high quality images amenable to clinician evaluation

  2. Safety of the device for the patient and the user: occurrence of adverse events [ Time Frame: 1 year ]
    Number of adverse events reported



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All eligible & consenting participants will be approached in a Skin Cancer clinic. Once the clinic consultation has been completed and a decision regarding their management has been made, patients will be invited to consent to the study.
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Patient presenting with any visible skin lesion for Dermatologist review on a body site amenable for optimal photographic imaging
  • Able and willing to comply with all study requirements.
  • Patient with a skin lesion that is clinically diagnosed by a Consultant Dermatologist as benign OR a suspicious skin lesion requiring excisional biopsy for histological diagnosis
  • Patient attending for a 'New' or 'Follow-up' consultation

Exclusion Criteria:

  • Patients aged under 18 years old
  • Patients unable to provide informed consent
  • Skin lesions in an anatomical site which is not suitable for photography including genital lesion, hair-bearing site or subungual lesion
  • Maximum size of lesion 25 mm
  • Lesion is at a site where previous surgery was undertaken
  • Lesion on a mucosal site

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497455


Locations
Layout table for location information
United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Barco NV

Layout table for additonal information
Responsible Party: Barco NV
ClinicalTrials.gov Identifier: NCT03497455     History of Changes
Other Study ID Numbers: 234237
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases