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The Impact of Total Body Skin Examination on Skin Cancer Detection

NCT00765193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14381

Last updated 2010-04-15

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Rainer Hofmann-Wellenhof, Prof. · Medical University of Graz, Austria

  • Giuseppe Argenziano, Prof. · University of Campania Luigi Vanvitelli

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00765193 on ClinicalTrials.gov