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

Primary Purpose

Non-melanoma Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
optical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-melanoma Skin Cancer focused on measuring dermoscopy, 3D total body photography, optical coherence tomography, in vivo reflectance confocal microscopy, total body photography, non-invasive imaging, confocal microscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik und Poliklinik für Dermatologie, Carl Gustav Carus Dresden, Medizinische Fakultät Technische Universität Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Management of non-melanoma skin cancer
Is management of non-melanoma skin cancer optimized after using non-invasive imaging devices like optical coherence tomography, in vivo reflectance confocal microscopy in comparison to examination with dermoscopy alone (number of primary excisions, number of biopsies, number of secondary inpatient stays due to positive biopsies, number of local treatments and lesions in which no treatment is necessary)

Secondary Outcome Measures

Comparison of diagnostic accuracy in optical coherence tomography and in vivo reflectance confocal microscopy in comparison to dermoscopy alone for non-melanoma skin cancer
Comparison of diagnostic accuracy of dermoscopy and optical coherence tomography and invivo reflectance confocal microscopy (is diagnostic accuracy of optical coherence tomography better or confocal microscopy better than in dermoscopy alone?
Diagnostic accuracy of the combination of optical coherence tomography and in vivo reflectance confocal microscopy in non-melanoma skin cancer
Does the combination of the results of optical coherence tomography and in vivo reflectance confocal microscopy in each lesion lead to an even better diagnostic accuracy than each device alone?
Diagnostic accuracy of 3D total body photography
Examination of diagnostic accuracy of 3D total body photography regarding non-melanoma skin cancer in comparison to examination with dermoscopy

Full Information

First Posted
April 24, 2023
Last Updated
April 24, 2023
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT05842421
Brief Title
Imaging Methods for the Diagnosis of Non-melanoma Skin Cancer and Its Precursors
Official Title
Imaging Methods Like Dermoscopy, Optical Coherence Tomography, in Vivo Reflectance Confocal Microscopy and 3D Total Body Photography for the Diagnosis of Non-melanoma Skin Cancer and Its Precursors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
June 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanoma Skin Cancer
Keywords
dermoscopy, 3D total body photography, optical coherence tomography, in vivo reflectance confocal microscopy, total body photography, non-invasive imaging, confocal microscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
randomized, controlled, unicentric study
Masking
None (Open Label)
Masking Description
participant and investigator, who does the clinical examination and planning of surgery are not blinded, but surgeons and pathologists are blinded to the groups
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
optical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography
Intervention Description
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
Primary Outcome Measure Information:
Title
Management of non-melanoma skin cancer
Description
Is management of non-melanoma skin cancer optimized after using non-invasive imaging devices like optical coherence tomography, in vivo reflectance confocal microscopy in comparison to examination with dermoscopy alone (number of primary excisions, number of biopsies, number of secondary inpatient stays due to positive biopsies, number of local treatments and lesions in which no treatment is necessary)
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Comparison of diagnostic accuracy in optical coherence tomography and in vivo reflectance confocal microscopy in comparison to dermoscopy alone for non-melanoma skin cancer
Description
Comparison of diagnostic accuracy of dermoscopy and optical coherence tomography and invivo reflectance confocal microscopy (is diagnostic accuracy of optical coherence tomography better or confocal microscopy better than in dermoscopy alone?
Time Frame
up to 24 months
Title
Diagnostic accuracy of the combination of optical coherence tomography and in vivo reflectance confocal microscopy in non-melanoma skin cancer
Description
Does the combination of the results of optical coherence tomography and in vivo reflectance confocal microscopy in each lesion lead to an even better diagnostic accuracy than each device alone?
Time Frame
up to 24 months
Title
Diagnostic accuracy of 3D total body photography
Description
Examination of diagnostic accuracy of 3D total body photography regarding non-melanoma skin cancer in comparison to examination with dermoscopy
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Klinik und Poliklinik für Dermatologie, Carl Gustav Carus Dresden, Medizinische Fakultät Technische Universität Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data that support the findings of this study are available on request from the principal investigator. The data are not publicly available due to privacy or ethical restrictions.

Learn more about this trial

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

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