RCM to Diagnose BCC - Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma
NCT ID: NCT03331874
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
352 participants
OBSERVATIONAL
2017-03-03
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
AI-aided Optical Coherence Tomography for the Detection of Basal Cell Carcinoma
NCT05817279
Reflectance Confocal Microscopy of Wounds During Moh's Surgery: Feasibility Testing of a Mosaicing Algorithm for Intraoperative Imaging of Cancer Margins
NCT01872130
Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Basal Cell Carcinomas
NCT07182240
cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
NCT06024629
In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin
NCT00588315
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The images taken of the tumour by the reflectance confocal microscope will be anonymised. These images will then be examined by a different in house dermatologist who has undergone training in examining confocal images. The images will also be sent to a dermatologist in Modena, Italy who is experienced in interpreting confocal microscopic images - both of these dermatologists will be blinded as to the patient's history and the results of the punch biopsy.
The biopsies will undergo routine processing in our histopathology laboratory as normal and will be analysed by a pathologist who will be unaware of the findings on confocal microscopy.
The patients will undergo one additional intervention over-and-above their standard investigation and treatment pathway. The treatment pathway for the patients will not be lengthened or shortened by their participation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Basal Cell Carcinoma
Diagnosis of Basal Cell Carcinoma by Reflectance confocal microscopy
Reflectance Confocal Microscopy
In-vivo microscope
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Reflectance Confocal Microscopy
In-vivo microscope
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Julie Dawson
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Julie Dawson
Research Services Manager
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer Garioch, Dr
Role: PRINCIPAL_INVESTIGATOR
Consultant Oncologist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
206698(59-03-16)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.