Basal Cell Carcinoma, Melanoma, Merkel Cell Carcinoma, Skin Cancer, Squamous Cell Carcinoma
Conditions
Brief 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.
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).
Interventions
OTHERInspection 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
Medical University of Graz
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. | one year |
Secondary
| Measure | Time frame |
|---|---|
| Whether a Systematic Screening is Related to a Higher Number of Unnecessary Excisions of Benign Skin Tumors Detected During the Screening. | one year |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Skin Cancer Screening Physicians examine, first, the problem area of skin and record result, and second, the full body and record result. | 14,381 |
| Total | 14,381 |
Baseline characteristics
| Characteristic | Skin Cancer Screening |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3354 Participants |
| Age, Categorical Between 18 and 65 years | 11027 Participants |
| Age Continuous | 49.4 years STANDARD_DEVIATION 18.4 |
| Region of Enrollment Argentina | 1001 participants |
| Region of Enrollment Australia | 43 participants |
| Region of Enrollment Austria | 997 participants |
| Region of Enrollment Brazil | 2010 participants |
| Region of Enrollment France | 999 participants |
| Region of Enrollment Italy | 7381 participants |
| Region of Enrollment Netherlands | 787 participants |
| Region of Enrollment Spain | 179 participants |
| Region of Enrollment Turkey | 984 participants |
| Sex: Female, Male Female | 7984 Participants |
| Sex: Female, Male Male | 6397 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.
Time frame: one year
Population: From a population of patients with various skin conditions, participants were considered for inclusion only if aged 18 years or more, and if suffering from focused skin complaints. Patients with diffuse skin complaints were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Problem Area Examination | Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. | 810 participants |
| Full Body Examination | Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. | 631 participants |
Comparison: The primary outcomes were the calculation of the absolute and relative risks of missing a skin cancer when TBSE is not performed, as well as the number of patients needed to examine by TBSE to find a skin cancer. The secondary outcome was to assess the magnitude of false-positive results obtained by TBSEp-value: <0.0195% CI: [2.12, 2.62]Regression, Logistic
Secondary
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