N/A
N=14,381
The Impact of Total Body Skin Examination on Skin Cancer Detection
Melanoma · Basal Cell Carcinoma · Squamous Cell Carcinoma · Merkel Cell Carcinoma · Skin Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00765193 ↗Enrolled (actual)
14,381
Serious AEs
—
Results posted
Apr 2010
Primary outcome: Primary: Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. — 810; 631 participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inspection of covered areas (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of Graz
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. |
810; 631 | <0.01 sig |
| SECONDARY Whether a Systematic Screening is Related to a Higher Number of Unnecessary Excisions of Benign Skin Tumors Detected During the Screening. |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00765193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.