The Impact of Total Body Skin Examination on Skin Cancer Detection (TBSE)

• ClinicalTrials.gov Identifier: NCT00765193
• Recruitment Status: Completed
• First Posted: October 2, 2008
• Results First Posted: April 15, 2010
• Last Update Posted: April 15, 2010
• Sponsor: Medical University of Graz
• Information provided by: Medical University of Graz

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.

Condition or disease	Intervention/treatment	Phase
Melanoma; Basal Cell Carcinoma; Squamous Cell Carcinoma; Merkel Cell Carcinoma; Skin Cancer	Other: Inspection of covered areas	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14381 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Impact of Total Body Skin Examination on Skin Cancer Detection
• Study Start Date: May 2008
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

Arm

Intervention/treatment

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 Name: Inspection of problem areas

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. [ Time Frame: one year ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 95 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Austria

Medical University of Graz-Austria: Department of Dermatology

Graz, Austria, 8046

Sponsors and Collaborators

Medical University of Graz

Investigators

• Principal Investigator: Rainer Hofmann-Wellenhof, Prof.; Medical University of Graz, Austria
• Principal Investigator: Giuseppe Argenziano, Prof.; University of Campania "Luigi Vanvitelli"

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Argenziano G, Zalaudek I, Hofmann-Wellenhof R, Bakos RM, Bergman W, Blum A, Broganelli P, Cabo H, Caltagirone F, Catricalà 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.

• Responsible Party: Prof. Rainer Hofmann-Wellenhof, Department of Dermatology; Medical University of Graz-Austria
• ClinicalTrials.gov Identifier: NCT00765193
• Other Study ID Numbers: 19-175 ex 07/08
• First Posted: October 2, 2008
• Results First Posted: April 15, 2010
• Last Update Posted: April 15, 2010
• Last Verified: April 2010

Additional relevant MeSH terms:

Carcinoma, Merkel Cell; Carcinoma; Carcinoma, Basal Cell; Skin Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasms, Basal Cell; Neoplasms by Site; Skin Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma