The Impact of Total Body Skin Examination on Skin Cancer Detection (TBSE)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Melanoma Basal Cell Carcinoma Squamous Cell Carcinoma Merkel Cell Carcinoma Skin Cancer |
Other: Inspection of covered areas |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Impact of Total Body Skin Examination on Skin Cancer Detection |
- Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. [ Time Frame: one year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 14381 |
| Study Start Date: | May 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Skin cancer screening |
Other: Inspection of covered areas
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.
Other Names:
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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).
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Austria | |
| Medical University of Graz-Austria: Department of Dermatology | |
| Graz, Austria, 8046 | |
| Principal Investigator: | Rainer Hofmann-Wellenhof, Prof. | Medical University of Graz-Austria |
| Principal Investigator: | Giuseppe Argenziano, Prof. | Second University of Naples |
More Information
No publications provided by Medical University of Graz
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Rainer Hofmann-Wellenhof, Department of Dermatology; Medical University of Graz-Austria |
| ClinicalTrials.gov Identifier: | NCT00765193 History of Changes |
| Other Study ID Numbers: | 19-175 ex 07/08 |
| Study First Received: | August 14, 2008 |
| Results First Received: | June 27, 2009 |
| Last Updated: | April 14, 2010 |
| Health Authority: | Austria: Ethikkommission |
Additional relevant MeSH terms:
|
Carcinoma Skin Neoplasms Carcinoma, Basal Cell Carcinoma, Merkel Cell Carcinoma, Squamous Cell Melanoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site |
Skin Diseases Neoplasms, Basal Cell Carcinoma, Neuroendocrine Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 16, 2013