Status:
COMPLETED
One-stop-shop Study for Treatment of Basal Cell Carcinoma Using Reflectance Confocal Microscopy
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
The Netherlands Cancer Institute
Conditions:
Carcinoma, Basal Cell
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Basal cell carcinoma (BCC) is the most common cancer diagnosed in white populations worldwide. The rising incidence of BCCs is becoming a major worldwide public health problem (1,11). Between 1973 and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02285790
Start Date
January 1 2015
End Date
April 1 2016
Last Update
April 13 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dutch Cancer Institute
Amsterdam, North Holland, Netherlands, 1066CX
2
Academic_Medical_Center
Amsterdam, North Holland, Netherlands, 1105AZ