In vivo reflectance confocal microscopy, a novel non-invasive tool for diagnosing skin cancer - a randomized controlled trial

Completed

• Conditions: 10040900; basal cell carcinoma; skin cancer

• Registration Number: NL-OMON42736
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 329

Inclusion Criteria

- Age *18 years
- Patient must be able to adhere to all requirements of the study
- Patient must be willing to give written informed consent
- Clinically diagnosed/ clinical suspicion of basal cell carcinoma

Exclusion Criteria

- Participating in other investigational research currently or in the previous 28 days before the study
- Patient is having a medical condition which excludes participating the research, according to the investigator
- Incapacitated subjects will not be included
- Lesion(s) on parts of the body which do not allow to adequately image the tumour with RCM.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective: To study whether in vivo reflectance confocal microscopy<br /><br>(RCM) can correctly identify the subtype of BCC.<br /><br><br /><br>Primary outcome measure is defined as:<br /><br>- Correct sub-typing of BCC after excision. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures:<br /><br>- QoL<br /><br>- Cost<br /><br>- QALY's<br /><br>- The ability of RCM to separate sBCC from other BCCs<br /><br>- Development of guidelines and protocols for future RCM users. </p><br>