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

In vivo reflectance confocal microscopy, a novel non-invasive tool for diagnosing skin cancer - a randomized controlled trial - RCM in basal cell carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42736
Enrollment
329
Registered
2015-11-30
Start date
2016-02-24
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

basal cell carcinoma skin cancer

Interventions

In one group, 3 mm skin biopsies will be performed, this is the conventionale regular diagnostic method which is invasive. In the other group, in vivo reflectance microscopy will be performed, this i

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Primary Objective: To study whether in vivo reflectance confocal microscopy (RCM) can correctly identify the subtype of BCC. Primary outcome measure is defined as: - Correct sub-typing of BCC after excision.

Secondary

MeasureTime frame
Secondary outcome measures: - QoL - Cost - QALY's - The ability of RCM to separate sBCC from other BCCs - Development of guidelines and protocols for future RCM users.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)