The Impact of Total Body Skin Examination on Skin Cancer Detection - Full Text View

Sponsored by:	Medical University of Graz
Information provided by:	Medical University of Graz
ClinicalTrials.gov Identifier:	NCT00765193

Purpose

This will be a cross-over trial 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: skin cancer detection rate (Total Body Skin Examination)

MedlinePlus related topics: Cancer Melanoma Skin Cancer

Drug Information available for: S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Crossover Assignment, Efficacy Study
Official Title:	The Impact of Total Body Skin Examination on Skin Cancer Detection

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:

to test the role of total body skin examination (TBSE) in detecting melanoma and non-melanoma skin cancers. [ 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 ]

Estimated Enrollment:	36000
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Physicians examine the problem area of skin ONLY and record result	Other: skin cancer detection rate (Total Body Skin Examination) skin cancer treatment according to established protocols
2 Physicians perform total body skin examination (TBSE) and record result	Other: skin cancer detection rate (Total Body Skin Examination) skin cancer treatment according to established protocols

Eligibility

Ages Eligible for Study:	18 Years and older
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	Recruiting
Graz, Austria, 8046
Contact: Rainer Hofmann-Wellenhof, Prof. +4331638580322 rainer.hofmann@meduni-graz.at
Sub-Investigator: Iris Zalaudek, Prof.

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

Responsible Party:	Department of Dermatology; Medical University of Graz-Austria ( Prof. Rainer Hofmann-Wellenhof )
Study ID Numbers:	19-175 ex 07/08
Study First Received:	August 14, 2008
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00765193
Health Authority:	Austria: Ethikkommission

Study placed in the following topic categories:

Skin Diseases
Carcinoma, Neuroendocrine
Squamous cell carcinoma
Imiquimod
Carcinoma, Basal Cell
Skin Neoplasms
Melanoma
Carcinoma
Neuroendocrine Tumors
Merkel cell cancer
Epidermoid carcinoma

Carcinoma, Merkel Cell
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Carcinoma, squamous cell
Neuroepithelioma
Nevus
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Neoplasms, Nerve Tissue
Neoplasms, Basal Cell
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 13, 2009