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Reflectance Confocal Microscopy in Basal Cell Carcinoma

NCT02623101 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2019-09-20

No results posted yet for this study

Summary

Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly.

Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma.

Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision.

Conditions

  • Carcinoma, Basal Cell

Interventions

DEVICE

Reflectance confocal microscopy

Non-invasive imaging of the lesion

PROCEDURE

Punch biopsy

Obtaining a skin sample of the suspicious lesion under local anesthetics

PROCEDURE

Surgical excision

Excision of the basal cell carcinoma lesion under local anesthetics

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Mavig GmbH

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • M JP Gerritsen, MD, PhD · Radboud University Medical Center, Department of Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02623101 on ClinicalTrials.gov