Reflectance Confocal Microscopy to Diagnose BCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

324 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-15

Study Completion Date

2019-12-28

Brief Summary

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It is proposed to undertake a study to determine the diagnostic utility of using RCM for the diagnosis of Basal Cell Carcinoma (BCC) in a tertiary referral centre as outlined by the recent NICE report (Nov 2015). This will allow an assessment of the potential to avoid diagnostic biopsy within the treatment pathway.

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Detailed Description

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Study Design This is an observational, non-randomised, non-controlled, prospective cohort study to look at the efficacy of in vivo RCM as a diagnostic tool in the diagnosis of BCC.

Study Hypothesis The hypothesis of this study is that the use of RCM is would enable a reduction in the number of diagnostic biopsies taken before definitive treatment of BCC by at least 50%.

The secondary hypothesis is that the intra- \& inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater (indicating good agreement).

Patients will be recruited from the outpatient clinic of Skin Care Network London.

Conditions

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Basal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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In-vivo imaging

Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older
2. Patient suspected of having a primary basal cell carcinoma that is a candidate for surgical treatment.
3. Patient willing and able to give informed consent

Exclusion Criteria

1. Recurrent or other higher-risk BCC
2. Patient with basal cell naevus syndrome
3. Patient treated with hedgehog inhibitor medication (vismodegib)
4. Patient not suitable for diagnostic biopsy
5. Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator
6. Patient with co-morbidities such as other skin disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No