MelanomaTBSENCT00765193
The Impact of Total Body Skin Examination on Skin Cancer Detection
A study testing Inspection of covered areas in people with Melanoma and Basal Cell Carcinoma, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- Inspection of covered areas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,381 participants
- Where
- 1 siteAustria
- Study dates
- May 2008to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz-Austria: Department of Dermatology
Graz, 8046
About this study
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).
Read more
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.
Read the 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).
- Conditions
- Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Merkel Cell Carcinoma, Skin Cancer
- Being tested
- Inspection of covered areas
- Medical subject headings
- Melanoma, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Carcinoma, Merkel Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspection of covered areasOther
Also called Inspection of problem 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.
| Study group | Role | What they receive |
|---|---|---|
| Skin cancer screening | Other | Not described Receives: Other: Inspection of covered areas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.
Measured: one year
Secondary outcomes (1)
Whether a Systematic Screening is Related to a Higher Number of Unnecessary Excisions of Benign Skin Tumors Detected During the Screening.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14,381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Rainer Hofmann-Wellenhof, Prof., Principal investigator, Medical University of GrazGiuseppe Argenziano, Prof., Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765193
- Sponsor's protocol ID
- 19-175 ex 07/08
- Acronym
- TBSE
- Status last verified
- Apr 2010
- First submitted
- 14 Aug 2008
- Last updated
- 15 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Argenziano G, Zalaudek I, Hofmann-Wellenhof R, Bakos RM, Bergman W, Blum A, Broganelli P, Cabo H, Caltagirone F, Catricala C, Coppini M, Dewes L, Francia MG, Garrone A, Turk BG, Ghigliotti G, Giacomel J, Gourhant JY, Hlavin G, Kukutsch N, Lipari D, Melchionda G, Ozdemir F, Pellacani G, Pellicano R, Puig S, Scalvenzi M, Sortino-Rachou AM, Virgili AR, Kittler H. Total body skin examination for skin cancer screening in patients with focused symptoms. J Am Acad Dermatol. 2012 Feb;66(2):212-9. doi: 10.1016/j.jaad.2010.12.039. Epub 2011 Jul 14.
PubMed 21757257
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Total Body Skin Examination on Skin Cancer Detection
- ClinicalTrials.gov ID
- NCT00765193
- Acronym / sponsor ID
- TBSE / 19-175 ex 07/08
- Conditions
- Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Merkel Cell Carcinoma, Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,381 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Posted 15 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin cancer screening | Other | Other: Inspection of covered areas |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspection of covered areasAlso: Inspection of problem areasClinicans 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 | Skin cancer screening |
Primary outcome
Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.
Time frame: one year
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21757257Argenziano G, Zalaudek I, Hofmann-Wellenhof R, Bakos RM, Bergman W, Blum A, Broganelli P, Cabo H, Caltagirone F, Catricala C, Coppini M, Dewes L, Francia MG, Garrone A, Turk BG, Ghigliotti G, Giacomel J, Gourhant JY, Hlavin G, Kukutsch N, Lipari D, Melchionda G, Ozdemir F, Pellacani G, Pellicano R, Puig S, Scalvenzi M, Sortino-Rachou AM, Virgili AR, Kittler H. Total body skin examination for skin cancer screening in patients with focused symptoms. J Am Acad Dermatol. 2012 Feb;66(2):212-9. doi: 10.1016/j.jaad.2010.12.039. Epub 2011 Jul 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Hofmann-Wellenhof, Prof. principal investigator
Medical University of Graz
Giuseppe Argenziano, Prof. principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspection of covered areas in people with Melanoma and Basal Cell Carcinoma, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00765193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2010.