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The Impact of Total Body Skin Examination on Skin Cancer Detection


N/A
18 Years
95 Years
Not Enrolling
Both
Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Merkel Cell Carcinoma, Skin Cancer

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Trial Information

The Impact of Total Body Skin Examination on Skin Cancer Detection


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).


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Rainer Hofmann-Wellenhof, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Graz-Austria

Authority:

Austria: Ethikkommission

Study ID:

19-175 ex 07/08

NCT ID:

NCT00765193

Start Date:

May 2008

Completion Date:

May 2009

Related Keywords:

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

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