Imaging Methods for the Diagnosis of Non-melanoma Skin Cancer and Its Precursors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2022-06-16

Brief Summary

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Prospective, unicentric study that examines if imaging devices like total body photography, dermoscopy, optical coherence tomography and in vivo reflectance confocal microscopy as an addition to clinical examination lead to a benefit for patients in the diagnosis of non-melanoma skin cancer and their precursors

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Detailed Description

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250 patients with lesions that are suspicious for non-melanoma skin cancer that had not yet had a biopsy, are randomized in 2 groups. The intervention group is examined with total body photography, dermoscopy, optical coherence tomography and in vivo reflectance confocal microscopy; the control group is examined with dermoscopy only. The aim of the study is to investigate whether these methods improve the early detection of non-melanoma skin cancer and their precursors. Examined are not only the differences in management of the lesions (excision, biopsy, local treatment or no treatment) and the diagnostic accuracy of the devices.

Conditions

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Non-melanoma Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

randomized, controlled, unicentric study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

participant and investigator, who does the clinical examination and planning of surgery are not blinded, but surgeons and pathologists are blinded to the groups

Study Groups

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Intervention group

After clinical examination, each lesion that is suspicious for non-melanoma skin cancer and/or its precursor, is examined with dermoscopy, optical coherence tomography, in vivo reflectance confocal microscopy and each patient gets 3D total body photography. Afterwards, decision for management of each lesion is made (excision, biopsy, local treatment or no treatment). Surgeons are blinded to the groups but get the planning of surgery of the investigator. Pathologists are blinded to the groups.

Group Type EXPERIMENTAL

optical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography

Intervention Type DEVICE

each lesion is in addition to examination with dermoscopy examined with optical coherence tomography, in vivo reflectance confocal microscopy, each patient is photographed with 3D total body photography

Control group

After clinical examination, each lesion that is suspicious for non-melanoma skin cancer and/or its precursor, is examined with dermoscopy as is the standard of care. Afterwards, decision for management of each lesion is made (excision, biopsy, local treatment or no treatment). Surgeons are blinded to the groups but get the planning of surgery of the investigator. Pathologists are blinded to the groups.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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optical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography

each lesion is in addition to examination with dermoscopy examined with optical coherence tomography, in vivo reflectance confocal microscopy, each patient is photographed with 3D total body photography

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with 1 or more lesions suspicious for non-melanoma skin cancer that had not yet had a biopsy or diagnostic excision of the lesions

Exclusion Criteria

* Patients with non-melanoma skin cancer that has already been examined with a punch biopsy or diagnostic excision
* Patients younger than 18 years
* Patients that are incapable of giving consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No