The Impact of Total Body Skin Examination on Skin Cancer Detection (TBSE)
Primary Purpose
Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Inspection of covered areas
Sponsored by
About this trial
This is an interventional diagnostic trial for Melanoma
Eligibility Criteria
Inclusion Criteria:
- Consecutive, unselected adult (18 years or more) patients with any skin disorders. Skin disorder must be localized on a limited body area and should NOT require total body skin examination (TBSE) to be diagnosed and/or treated.
Exclusion Criteria:
- Patients who ask for or need TBSE as the main reason for consultation. A patient must be also excluded if a significant part of the body should be undressed for diagnosis and/or treatment (i.e. if the shirt or trousers should be removed for diagnosis and/or treatment, then the patient must be excluded).
- patients under the age of 18 years.
- patients who do not agree to get TBSE.
Sites / Locations
- Medical University of Graz-Austria: Department of Dermatology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Skin cancer screening
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.
Secondary Outcome Measures
Whether a Systematic Screening is Related to a Higher Number of Unnecessary Excisions of Benign Skin Tumors Detected During the Screening.
Full Information
NCT ID
NCT00765193
First Posted
August 14, 2008
Last Updated
April 14, 2010
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT00765193
Brief Title
The Impact of Total Body Skin Examination on Skin Cancer Detection
Acronym
TBSE
Official Title
The Impact of Total Body Skin Examination on Skin Cancer Detection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Graz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This will be a study where all patients will undergo a two-step procedure:
Step 1 - Physicians examine the problem area of skin ONLY and record result. Step 2 - Physicians perform TBSE and record result. Eventual lesions suggestive of melanoma and non-melanoma skin cancers will be recorded after step 1 or step 2 examination and will be finally biopsied and histopathologically diagnosed. Exceptions to biopsy may include patients with multiple non-melanoma skin cancers (e.g. actinic keratoses or basal cell carcinomas).
Each center will be provided with an electronic data sheet for patients record, or alternatively, with a paper record form.
Endpoints of the study are new parameters concerning the standard of care for skin cancer screening. We expect to conclude that TBSE enables clinicians discovering an increased number of skin cancers thus resulting in earlier detection.
Detailed Description
Clinicans performed a two-step examination for skin cancer, with clinical examination of individual lesions was aided by the use of dermoscopy, as needed. In the first step, physicians performed inspection of problem areas and uncovered areas only, and lesions suggestive of melanoma or non-melanoma skin cancer were noted. In the second step, TBSE was performed. Following both examinations, lesions suggestive of melanoma or non-melanoma skin cancer were excised or biopsied. Histopathologic diagnosis was recorded for each of the biopsied or excised lesions.
Statistical analysis: We calculated absolute risks as the proportion of individuals with the target disease divided by all individuals at risk. The number needed to examine was calculated by dividing the individuals at risk by the numbers of individuals with the target disease. Confidence intervals for proportions were calculated using standard formulas based on the binomial distribution. Chi square tests were used for comparison of proportions.
Continuous variables are presented as mean and standard deviation (SD) unless otherwise specified. For univariate and multivariate analyses we used odds ratios derived from logistic regression to estimate relative risks and their confidence intervals. All p-values reported are 2-tailed. Statistical significance is defined as P <0.05. Statistical analysis was performed using SPSS software, version 16.0 (SPSS, Chicago, Ill, US).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Merkel Cell Carcinoma, Skin Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14381 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skin cancer screening
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Inspection of covered areas
Other Intervention Name(s)
Inspection of problem areas
Intervention Description
Clinicans performed a two-step examination for skin cancer, with clinical examination of individual lesions was aided by the use of dermoscopy, as needed. In the first step, physicians performed inspection of problem areas and uncovered areas only, and lesions suggestive of melanoma or non-melanoma skin cancer were noted. In the second step, TBSE was performed. Following both examinations, lesions suggestive of melanoma or non-melanoma skin cancer were excised or biopsied. Histopathologic diagnosis was recorded for each of the biopsied or excised lesions.
Primary Outcome Measure Information:
Title
Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Whether a Systematic Screening is Related to a Higher Number of Unnecessary Excisions of Benign Skin Tumors Detected During the Screening.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Consecutive, unselected adult (18 years or more) patients with any skin disorders. Skin disorder must be localized on a limited body area and should NOT require total body skin examination (TBSE) to be diagnosed and/or treated.
Exclusion Criteria:
Patients who ask for or need TBSE as the main reason for consultation. A patient must be also excluded if a significant part of the body should be undressed for diagnosis and/or treatment (i.e. if the shirt or trousers should be removed for diagnosis and/or treatment, then the patient must be excluded).
patients under the age of 18 years.
patients who do not agree to get TBSE.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Hofmann-Wellenhof, Prof.
Organizational Affiliation
Medical University of Graz, Austria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giuseppe Argenziano, Prof.
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz-Austria: Department of Dermatology
City
Graz
ZIP/Postal Code
8046
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
21757257
Citation
Argenziano G, Zalaudek I, Hofmann-Wellenhof R, Bakos RM, Bergman W, Blum A, Broganelli P, Cabo H, Caltagirone F, Catricala C, Coppini M, Dewes L, Francia MG, Garrone A, Turk BG, Ghigliotti G, Giacomel J, Gourhant JY, Hlavin G, Kukutsch N, Lipari D, Melchionda G, Ozdemir F, Pellacani G, Pellicano R, Puig S, Scalvenzi M, Sortino-Rachou AM, Virgili AR, Kittler H. Total body skin examination for skin cancer screening in patients with focused symptoms. J Am Acad Dermatol. 2012 Feb;66(2):212-9. doi: 10.1016/j.jaad.2010.12.039. Epub 2011 Jul 14.
Results Reference
derived
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The Impact of Total Body Skin Examination on Skin Cancer Detection
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