Clinical trial · Interventional
One-stop-shop Study for Treatment of Basal Cell Carcinoma Using Reflectance Confocal Microscopy
Treatment of Basal Cell Carcinoma Using a One-stop-shop With Reflectance Confocal Microscopy: a Randomized Controlled Multicenter Trial
NCT02285790CI-TRIAL-00021717B-OSScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the efficacy and safety of the one-stop-shop concept, using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to surgical management of new primary basal cell carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Basal Cell | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Punch biopsy | Procedure | — | UNRESOLVED |
| Reflectance confocal microscopy | Device | — | UNRESOLVED |
| Surgical excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RCM-OSS procedure
- description
- The Vivascope 1500 will be used (CE certified, Lucid Technologies, Henrietta, NY, USA). Reflectance confocal microscopy (RCM) imaging will be performed for intended use only and interpreted on the Vivascope workstation by two investigators independently at both study locations. The investigators will be blinded to the results of the reference standard. After RCM imaging subjects will receive OSS surgical excision according to subtype. Clinically suspected primary BCCs that are not confirmed by RCM will also receive surgical treatment with a margin of 3mm.
- interventionNames
- Device: Reflectance confocal microscopy
- Procedure: Surgical excision
- type
- ACTIVE_COMPARATOR
- label
- Standard of care procedure
- description
- Clinical suspected primary BCCs, of all subtypes, will be diagnosed by conventional 3mm punch biopsy of the most elevated part of the lesion. Punch biopsies will be performed under local anesthetics using 1% xylocaine/adrenaline. HE stained sections of the punch biopsies will be evaluated by an experienced board certified pathologist. Subjects will receive surgical excision according to subtype within 6 weeks after punch biopsy has been performed. Clinically suspected new primary BCCs that are not confirmed by punch biopsy will also receive surgical treatment with a margin of 3mm.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with clinically suspected new primary BCC as assessed by an experienced board certified dermatologist * Patients seen at the outpatient clinic before 12h00 AM will be eligible to participate * Patient is willing and able to give written informed consent * BCC lesion is suitable for conventional surgical excision under local anesthetics * BCC lesion is present since at least 1 month Exclusion Criteria: * BCC lesion in a high-risk location of the face (H-zone and ears) * Contra-indication for conventional surgical excision (primary surgical closure seems not achievable) * Recurrent BCC lesion (BCC that has been previously unsuccessfully treated) Macroscopic ulcerating BCC lesions (not feasible for RCM analysis due to technical reasons) * Patients with basal cell nevus syndrome * Patients treated with hedgehog inhibitor medication * Patients with a history of hypersensitivity to and/ or a history of allergy to local anesthesia * Unavailability within the following 6 weeks (for example due to holiday or sports) * Patients not competent to understand the procedures involved
References
Publications (7)
- BACKGROUNDLomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x. PMID 22251204
- BACKGROUNDSauermann 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 12236882
- BACKGROUNDGonzalez 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 12451371
- BACKGROUNDvan der Geer S, Reijers HA, van Tuijl HF, de Vries H, Krekels GA. Need for a new skin cancer management strategy. Arch Dermatol. 2010 Mar;146(3):332-6. doi: 10.1001/archdermatol.2010.1. PMID 20231509
- BACKGROUNDvan der Geer S, Frunt M, Romero HL, Dellaert NP, Jansen-Vullers MH, Demeyere TB, Neumann HA, Krekels GA. One-stop-shop treatment for basal cell carcinoma, part of a new disease management strategy. J Eur Acad Dermatol Venereol. 2012 Sep;26(9):1154-7. doi: 10.1111/j.1468-3083.2011.04184.x. Epub 2011 Jul 19. PMID 21771105
- BACKGROUNDvan Cranenburgh OD, de Korte J, Sprangers MA, de Rie MA, Smets EM. Satisfaction with treatment among patients with psoriasis: a web-based survey study. Br J Dermatol. 2013 Aug;169(2):398-405. doi: 10.1111/bjd.12372. PMID 23565643
- DERIVEDKadouch DJ, Wolkerstorfer A, Elshot Y, Zupan-Kajcovski B, Crijns MB, Starink MV, Bekkenk MW, van der Wal AC, Spuls PI, de Rie MA. Treatment of Basal Cell Carcinoma Using a One-Stop-Shop With Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial. JMIR Res Protoc. 2015 Sep 10;4(3):e109. doi: 10.2196/resprot.4303.