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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00765193
First received: August 14, 2008
Last updated: April 14, 2010
Last verified: April 2010
  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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • Inspection of problem areas
  • Inspection of covered areas

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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765193

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. 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 April 16, 2014