The Impact of Total Body Skin Examination on Skin Cancer Detection

Melanoma Clinical Trial

— TBSE  

Official title:

The Impact of Total Body Skin Examination on Skin Cancer Detection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765193
• Other study ID #: 19-175 ex 07/08
• Status: Completed
• Phase: N/A
• First received: August 14, 2008
• Last updated: April 14, 2010
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: April 2010
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14381
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Merkel Cell
• Carcinoma, Squamous Cell
• Melanoma
• Merkel Cell Carcinoma
• Skin Cancer
• Skin Neoplasms
• Squamous Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Graz-Austria: Department of Dermatology	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.		one year	No
Secondary	Whether a Systematic Screening is Related to a Higher Number of Unnecessary Excisions of Benign Skin Tumors Detected During the Screening.		one year	No