The Impact of Total Body Skin Examination on Skin Cancer Detection

NCT ID: NCT00765193

Last Updated: 2010-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14381 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-05-31

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).

Conditions

Melanoma; Basal Cell Carcinoma; Squamous Cell Carcinoma; Merkel Cell Carcinoma; Skin Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Skin cancer screening

Group Type: OTHER

Inspection of covered areas

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Inspection of problem areas

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Department of Dermatology; Medical University of Graz-Austria

Principal Investigators

Rainer Hofmann-Wellenhof, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Austria

Giuseppe Argenziano, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Locations

Medical University of Graz-Austria: Department of Dermatology

Graz, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 21757257 (View on PubMed)

Other Identifiers

19-175 ex 07/08

Identifier Type: -

Identifier Source: org_study_id