NCT03331874

Brief Summary

Basal cell carcinoma (BCC) is the commonest non melanoma skin cancer in the UK and its incidence is rising. The Norfolk and Norwich University Hospital Foundation Trust (NNUHFT) see and excise approximately 3,000 new cases of BCC each year. Many of these patients have a biopsy to confirm their diagnosis before being listed for surgical excision. In vivo reflectance confocal microscopy (RCM) involves using a machine which can examine the upper layers of the skin non invasively. In clinically suspicious lesions, the Investigators will use RCM prior to biopsy with the aim of demonstrating that RCM can accurately diagnose BCC. The aim of this study is to determine the feasibility and utility of using RCM for the diagnosis of BCC in the NHS setting, thereby shortening the patient pathway and effectively using limited public resources. If the Investigators' study shows that RCM can accurately diagnose BCC in these patients then this would prevent the need for biopsy as a routine in these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.7 years

First QC Date

November 1, 2017

Last Update Submit

October 7, 2020

Conditions

Basal Cell Carcinoma

Keywords

confocalbasalcarcinoma

Outcome Measures

Primary Outcomes (1)

  • Specificity & Sensitivity of RCM in diagnosing BCC compared to standard histology

    Specificity \& Sensitivity of RCM in diagnosing BCC compared to standard histology

    18 months

Secondary Outcomes (1)

  • Inter- & intra-observer agreement in assessing RCM images

    18 months

Study Arms (1)

Basal Cell Carcinoma

Diagnosis of Basal Cell Carcinoma by Reflectance confocal microscopy

Diagnostic Test: Reflectance Confocal Microscopy

Interventions

Reflectance Confocal MicroscopyDIAGNOSTIC_TEST

In-vivo microscope

Basal Cell Carcinoma

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

See Above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Publications (12)

  • Levell NJ, Igali L, Wright KA, Greenberg DC. Basal cell carcinoma epidemiology in the UK: the elephant in the room. Clin Exp Dermatol. 2013 Jun;38(4):367-9. doi: 10.1111/ced.12016. Epub 2013 Mar 18.

    PMID: 23496262BACKGROUND

  • Sauermann K, Gambichler T, Wilmert M, Rotterdam S, Stucker M, Altmeyer P, Hoffmann K. Investigation of basal cell carcinoma [correction of carcionoma] by confocal laser scanning microscopy in vivo. Skin Res Technol. 2002 Aug;8(3):141-7. doi: 10.1034/j.1600-0846.2002.20345.x.

    PMID: 12236882BACKGROUND

  • Gonzalez S, Tannous Z. Real-time, in vivo confocal reflectance microscopy of basal cell carcinoma. J Am Acad Dermatol. 2002 Dec;47(6):869-74. doi: 10.1067/mjd.2002.124690.

    PMID: 12451371BACKGROUND

  • Goldgeier M, Fox CA, Zavislan JM, Harris D, Gonzalez S. Noninvasive imaging, treatment, and microscopic confirmation of clearance of basal cell carcinoma. Dermatol Surg. 2003 Mar;29(3):205-10. doi: 10.1046/j.1524-4725.2003.29050.x.

    PMID: 12614409BACKGROUND

  • Marra DE, Torres A, Schanbacher CF, Gonzalez S. Detection of residual basal cell carcinoma by in vivo confocal microscopy. Dermatol Surg. 2005 May;31(5):538-41. doi: 10.1111/j.1524-4725.2005.31157.

    PMID: 15962737BACKGROUND

  • Nori S, Rius-Diaz F, Cuevas J, Goldgeier M, Jaen P, Torres A, Gonzalez S. Sensitivity and specificity of reflectance-mode confocal microscopy for in vivo diagnosis of basal cell carcinoma: a multicenter study. J Am Acad Dermatol. 2004 Dec;51(6):923-30. doi: 10.1016/j.jaad.2004.06.028.

    PMID: 15583584BACKGROUND

  • Longo C, Farnetani F, Ciardo S, Cesinaro AM, Moscarella E, Ponti G, Zalaudek I, Argenziano G, Pellacani G. Is confocal microscopy a valuable tool in diagnosing nodular lesions? A study of 140 cases. Br J Dermatol. 2013 Jul;169(1):58-67. doi: 10.1111/bjd.12259.

    PMID: 23374159BACKGROUND

  • Gerger A, Koller S, Weger W, Richtig E, Kerl H, Samonigg H, Krippl P, Smolle J. Sensitivity and specificity of confocal laser-scanning microscopy for in vivo diagnosis of malignant skin tumors. Cancer. 2006 Jul 1;107(1):193-200. doi: 10.1002/cncr.21910.

    PMID: 16615102BACKGROUND

  • Eichert S, Mohrle M, Breuninger H, Rocken M, Garbe C, Bauer J. Diagnosis of cutaneous tumors with in vivo confocal laser scanning microscopy. J Dtsch Dermatol Ges. 2010 Jun;8(6):400-10. doi: 10.1111/j.1610-0387.2010.07333.x. Epub 2010 Feb 5. English, German.

    PMID: 20141551BACKGROUND

  • Guitera P, Menzies SW, Longo C, Cesinaro AM, Scolyer RA, Pellacani G. In vivo confocal microscopy for diagnosis of melanoma and basal cell carcinoma using a two-step method: analysis of 710 consecutive clinically equivocal cases. J Invest Dermatol. 2012 Oct;132(10):2386-2394. doi: 10.1038/jid.2012.172. Epub 2012 Jun 21.

    PMID: 22718115BACKGROUND

  • Peppelman M, Wolberink EA, Blokx WA, van de Kerkhof PC, van Erp PE, Gerritsen MJ. In vivo diagnosis of basal cell carcinoma subtype by reflectance confocal microscopy. Dermatology. 2013;227(3):255-62. doi: 10.1159/000354762. Epub 2013 Oct 18.

    PMID: 24158236BACKGROUND

  • Castro RP, Stephens A, Fraga-Braghiroli NA, Oliviero MC, Rezze GG, Rabinovitz H, Scope A. Accuracy of in vivo confocal microscopy for diagnosis of basal cell carcinoma: a comparative study between handheld and wide-probe confocal imaging. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1164-9. doi: 10.1111/jdv.12780. Epub 2014 Oct 22.

    PMID: 25338750BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal CellCarcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Jennifer Garioch, Dr

    Consultant Oncologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Services Manager

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 6, 2017

Study Start

March 3, 2017

Primary Completion

November 27, 2019

Study Completion

December 31, 2019

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)