Melanoma (Skin Cancer)Skin Cancer AmNCT07831083
Skin Cancer Among Outdoor Workers
An observational study of Melanoma (Skin Cancer) and Basal Cell Carcinoma of Skin, run by Assuta Medical Center at 1 site in Israel.
Trial summary
This observational study examines skin cancer among workers who may have prolonged occupational exposure to sunlight. Long-term exposure to ultraviolet radiation from the sun is an important risk factor for several types of skin cancer, particularly among people who work outdoors for many years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin Cancer), Basal Cell Carcinoma of Skin, Squamous Cell Cancer of Head and Neck (SCCHN)
- How many people
- 10,000 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2018to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Records without a diagnosis of malignant skin cancer. * Benign skin lesions or nonmalignant dermatologic conditions. * Records in which the diagnosis cannot be sufficiently identified or classified as skin cancer. * Duplicate records representing the same determination or event when applicable. * Records lacking sufficient information for inclusion in the primary analysis.
Who may be able to join
- Individuals with a documented or recognized occupational skin cancer during the predefined study period.
- Skin cancer potentially associated with occupational exposure to solar ultraviolet radiation.
- Diagnoses including basal-cell carcinoma, squamous-cell carcinoma, melanoma, or other malignant skin tumors when diagnostic classification is available.
- Availability of sufficient administrative, occupational, medical, or disability-related information for inclusion in the analysis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skin Cancer Among Outdoor Workers: A Nationwide Analysis of Occupational Claims and Disability Burden
This observational study examines skin cancer among workers who may have prolonged occupational exposure to sunlight. Long-term exposure to ultraviolet radiation from the sun is an important risk factor for several types of skin cancer, particularly among people who work outdoors for many years.
The study will use routinely collected administrative and medical data to describe the characteristics of workers with recognized skin cancer, including age, sex, geographic region, type of skin cancer, occupational characteristics, and disability-related outcomes. Trends over time and differences between population groups will also be evaluated when the available data permit.
The purpose of the study is to better understand the burden of skin cancer associated with occupational sun exposure and to identify groups of workers who may be at increased risk. The findings may help support improved prevention, earlier detection, workplace sun-protection measures, and occupational health policies for outdoor workers.
Read the detailed description
Occupational exposure to solar ultraviolet radiation is a recognized carcinogenic hazard and is particularly relevant for individuals who spend substantial portions of their working lives outdoors. Chronic cumulative exposure to sunlight may increase the risk of skin malignancies, especially keratinocyte cancers such as squamous-cell carcinoma and basal-cell carcinoma. The relationship between occupational sunlight exposure and melanoma is more complex and will therefore be evaluated separately when diagnostic information permits.
This retrospective observational study will evaluate administrative and medical records of individuals with occupationally relevant skin cancer. The study will characterize the demographic, geographic, occupational, clinical, and disability-related features of affected workers. Available data will be used to examine age and sex distributions, geographic variation, diagnostic categories, patterns over time, and occupational characteristics associated with prolonged outdoor work and potential solar ultraviolet exposure.
Skin cancers will be classified according to the diagnostic information available in the database. Where possible, basal-cell carcinoma, squamous-cell carcinoma, melanoma, and other malignant skin tumors will be evaluated separately because their epidemiology and relationship with ultraviolet radiation differ. Disability-related characteristics, including the type and degree of recognized impairment and whether disability determinations were temporary or permanent, will also be evaluated when available.
Temporal trends will be examined to determine whether the number and proportion of occupational skin-cancer cases changed during the study period. Geographic and demographic differences will also be explored to identify groups with a higher burden of disease. Where appropriate denominators are available, rates will be calculated using the relevant working population as the population at risk. When appropriate population denominators are not available, results will be reported as distributions and proportions of claims rather than population incidence rates.
Because skin cancer generally develops after cumulative ultraviolet exposure over many years, the study will not assume that the year in which a cancer was diagnosed or recognized represents the period during which the relevant occupational exposure occurred. Instead, occupational solar exposure will be considered a long-term cumulative exposure.
The study is intended to improve understanding of the occupational burden of skin cancer among outdoor workers and to identify demographic, geographic, and occupational patterns that may be useful for prevention. Findings may contribute to improved occupational health strategies, including sun-protection policies, worker education, use of protective clothing and sunscreen, reduction of intense midday ultraviolet exposure when feasible, and targeted skin surveillance for workers with prolonged occupational exposure to sunlight.
- Conditions
- Melanoma (Skin Cancer), Basal Cell Carcinoma of Skin, Squamous Cell Cancer of Head and Neck (SCCHN), Work Injury, Sun Exposure
- Keywords
- sun exposure, skin cancer
- Medical subject headings
- Melanoma, Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Skin cancer in workers under sun | Workers with documented or recognized skin cancer potentially associated with occupational exposure to solar ultraviolet radiation. The cohort includes individuals with available administrative, occupational, medical, and disability-related records during the study period. Skin cancers will be classified, when data permit, as basal-cell carcinoma, squamous-cell carcinoma, melanoma, or other malignant skin tumors. Demographic characteristics, occupational features, geographic distribution, temporal trends, and disability outcomes will be evaluated. This is an observational study; no intervention or treatment is assigned as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Proportion of Recognized Occupational Skin Cancer Cases by Cancer Type
Cancer type was determined at the initial recognition of each occupational skin cancer claim. The number and proportion of recognized cases were summarized by cancer type, including basal-cell carcinoma, squamous-cell carcinoma, melanoma, and other malignant skin tumors, for claims recorded in the national administrative database from January 1, 2018 through December 31, 2025.
Measured: Baseline (at initial recognition of the occupational skin cancer claim)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Jan 2018
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831083
- Sponsor's protocol ID
- BTL003-26
- Acronym
- Skin Cancer Am
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study uses confidential administrative, medical, occupational, and disability records that are subject to privacy, ethical, and institutional data-protection restrictions. The investigators are not authorized to distribute individual-level records to external researchers. Study results will be reported only in aggregated or appropriately de-identified form. Additional information regarding the study methodology, statistical analyses, and aggregated results may be made available upon reasonable request, subject to applicable institutional and regulatory requirements.
Publications
Schmitt J, Seidler A, Diepgen TL, Bauer A. Occupational ultraviolet light exposure increases the risk for the development of cutaneous squamous cell carcinoma: a systematic review and meta-analysis. Br J Dermatol. 2011 Feb;164(2):291-307. doi: 10.1111/j.1365-2133.2010.10118.x.
PubMed 21054335Pega F, Momen NC, Streicher KN, Leon-Roux M, Neupane S, Schubauer-Berigan MK, Schuz J; Technical Advisory Group on Occupational Burden of Disease Estimation; Baker M, Driscoll T, Guseva Canu I, Kiiver HM, Li J, Nwanaji-Enwerem JC, Turner MC, Viegas S, Villeneuve PJ. Global, regional and national burdens of non-melanoma skin cancer attributable to occupational exposure to solar ultraviolet radiation for 183 countries, 2000-2019: A systematic analysis from the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury. Environ Int. 2023 Nov;181:108226. doi: 10.1016/j.envint.2023.108226. Epub 2023 Nov 8.
PubMed 37945424Wendt A, Mohner M. Occupational solar exposure and basal cell carcinoma. A review of the epidemiologic literature with meta-analysis focusing on particular methodological aspects. Eur J Epidemiol. 2024 Jan;39(1):13-25. doi: 10.1007/s10654-023-01061-w. Epub 2024 Jan 3.
PubMed 38170370Slavinsky V, Helmy J, Vroman J, Valdebran M. Solar ultraviolet radiation exposure in workers with outdoor occupations: a systematic review and call to action. Int J Dermatol. 2024 Mar;63(3):288-297. doi: 10.1111/ijd.16877. Epub 2023 Oct 18.
PubMed 37853576Kristensen I, Iversen IB, Fenger-Gron M, Kolstad HA, Wurtz ET, Turner MC, Grandahl K, Schmidt SAJ, Stokholm ZA. Occupational solar ultraviolet radiation and incidence of non-melanoma skin cancer in a nationwide cohort. Environ Pollut. 2025 Dec 1;386:127275. doi: 10.1016/j.envpol.2025.127275. Epub 2025 Oct 15.
PubMed 41106796
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Cancer Among Outdoor Workers: A Nationwide Analysis of Occupational Claims and Disability Burden
- ClinicalTrials.gov ID
- NCT07831083
- Acronym / sponsor ID
- Skin Cancer Am / BTL003-26
- Conditions
- Melanoma (Skin Cancer), Basal Cell Carcinoma of Skin, Squamous Cell Cancer of Head and Neck (SCCHN), Work Injury, Sun Exposure
- Keywords
- sun exposure, skin cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study examines skin cancer among workers who may have prolonged occupational exposure to sunlight. Long-term exposure to ultraviolet radiation from the sun is an important risk factor for several types of skin cancer, particularly among people who work outdoors for many years.
The study will use routinely collected administrative and medical data to describe the characteristics of workers with recognized skin cancer, including age, sex, geographic region, type of skin cancer, occupational characteristics, and disability-related outcomes. Trends over time and differences between population groups will also be evaluated when the available data permit.
The purpose of the study is to better understand the burden of skin cancer associated with occupational sun exposure and to identify groups of workers who may be at increased risk. The findings may help support improved prevention, earlier detection, workplace sun-protection measures, and occupational health policies for outdoor workers.
Detailed description
Occupational exposure to solar ultraviolet radiation is a recognized carcinogenic hazard and is particularly relevant for individuals who spend substantial portions of their working lives outdoors. Chronic cumulative exposure to sunlight may increase the risk of skin malignancies, especially keratinocyte cancers such as squamous-cell carcinoma and basal-cell carcinoma. The relationship between occupational sunlight exposure and melanoma is more complex and will therefore be evaluated separately when diagnostic information permits.
This retrospective observational study will evaluate administrative and medical records of individuals with occupationally relevant skin cancer. The study will characterize the demographic, geographic, occupational, clinical, and disability-related features of affected workers. Available data will be used to examine age and sex distributions, geographic variation, diagnostic categories, patterns over time, and occupational characteristics associated with prolonged outdoor work and potential solar ultraviolet exposure.
Skin cancers will be classified according to the diagnostic information available in the database. Where possible, basal-cell carcinoma, squamous-cell carcinoma, melanoma, and other malignant skin tumors will be evaluated separately because their epidemiology and relationship with ultraviolet radiation differ. Disability-related characteristics, including the type and degree of recognized impairment and whether disability determinations were temporary or permanent, will also be evaluated when available.
Temporal trends will be examined to determine whether the number and proportion of occupational skin-cancer cases changed during the study period. Geographic and demographic differences will also be explored to identify groups with a higher burden of disease. Where appropriate denominators are available, rates will be calculated using the relevant working population as the population at risk. When appropriate population denominators are not available, results will be reported as distributions and proportions of claims rather than population incidence rates.
Because skin cancer generally develops after cumulative ultraviolet exposure over many years, the study will not assume that the year in which a cancer was diagnosed or recognized represents the period during which the relevant occupational exposure occurred. Instead, occupational solar exposure will be considered a long-term cumulative exposure.
The study is intended to improve understanding of the occupational burden of skin cancer among outdoor workers and to identify demographic, geographic, and occupational patterns that may be useful for prevention. Findings may contribute to improved occupational health strategies, including sun-protection policies, worker education, use of protective clothing and sunscreen, reduction of intense midday ultraviolet exposure when feasible, and targeted skin surveillance for workers with prolonged occupational exposure to sunlight.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin cancer in workers under sun | – | –Workers with documented or recognized skin cancer potentially associated with occupational exposure to solar ultraviolet radiation. The cohort includes individuals with available administrative, occupational, medical, and disability-related records during the study period. Skin cancers will be classified, when data permit, as basal-cell carcinoma, squamous-cell carcinoma, melanoma, or other malignant skin tumors. Demographic characteristics, occupational features, geographic distribution, temporal trends, and disability outcomes will be evaluated. This is an observational study; no intervention or treatment is assigned as part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Records without a diagnosis of malignant skin cancer. * Benign skin lesions or nonmalignant dermatologic conditions. * Records in which the diagnosis cannot be sufficiently identified or classified as skin cancer. * Duplicate records representing the same determination or event when applicable. * Records lacking sufficient information for inclusion in the primary analysis.
Key inclusion criteria (4 listed)
- Individuals with a documented or recognized occupational skin cancer during the predefined study period.
- Skin cancer potentially associated with occupational exposure to solar ultraviolet radiation.
- Diagnoses including basal-cell carcinoma, squamous-cell carcinoma, melanoma, or other malignant skin tumors when diagnostic classification is available.
- Availability of sufficient administrative, occupational, medical, or disability-related information for inclusion in the analysis
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number and Proportion of Recognized Occupational Skin Cancer Cases by Cancer Type
Time frame: Baseline (at initial recognition of the occupational skin cancer claim)
Cancer type was determined at the initial recognition of each occupational skin cancer claim. The number and proportion of recognized cases were summarized by cancer type, including basal-cell carcinoma, squamous-cell carcinoma, melanoma, and other malignant skin tumors, for claims recorded in the national administrative database from January 1, 2018 through December 31, 2025.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 21054335Schmitt J, Seidler A, Diepgen TL, Bauer A. Occupational ultraviolet light exposure increases the risk for the development of cutaneous squamous cell carcinoma: a systematic review and meta-analysis. Br J Dermatol. 2011 Feb;164(2):291-307. doi: 10.1111/j.1365-2133.2010.10118.x.
- Background: PubMed 37945424Pega F, Momen NC, Streicher KN, Leon-Roux M, Neupane S, Schubauer-Berigan MK, Schuz J; Technical Advisory Group on Occupational Burden of Disease Estimation; Baker M, Driscoll T, Guseva Canu I, Kiiver HM, Li J, Nwanaji-Enwerem JC, Turner MC, Viegas S, Villeneuve PJ. Global, regional and national burdens of non-melanoma skin cancer attributable to occupational exposure to solar ultraviolet radiation for 183 countries, 2000-2019: A systematic analysis from the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury. Environ Int. 2023 Nov;181:108226. doi: 10.1016/j.envint.2023.108226. Epub 2023 Nov 8.
- Background: PubMed 38170370Wendt A, Mohner M. Occupational solar exposure and basal cell carcinoma. A review of the epidemiologic literature with meta-analysis focusing on particular methodological aspects. Eur J Epidemiol. 2024 Jan;39(1):13-25. doi: 10.1007/s10654-023-01061-w. Epub 2024 Jan 3.
- Background: PubMed 37853576Slavinsky V, Helmy J, Vroman J, Valdebran M. Solar ultraviolet radiation exposure in workers with outdoor occupations: a systematic review and call to action. Int J Dermatol. 2024 Mar;63(3):288-297. doi: 10.1111/ijd.16877. Epub 2023 Oct 18.
- Background: PubMed 41106796Kristensen I, Iversen IB, Fenger-Gron M, Kolstad HA, Wurtz ET, Turner MC, Grandahl K, Schmidt SAJ, Stokholm ZA. Occupational solar ultraviolet radiation and incidence of non-melanoma skin cancer in a nationwide cohort. Environ Pollut. 2025 Dec 1;386:127275. doi: 10.1016/j.envpol.2025.127275. Epub 2025 Oct 15.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study uses confidential administrative, medical, occupational, and disability records that are subject to privacy, ethical, and institutional data-protection restrictions. The investigators are not authorized to distribute individual-level records to external researchers. Study results will be reported only in aggregated or appropriately de-identified form. Additional information regarding the study methodology, statistical analyses, and aggregated results may be made available upon reasonable request, subject to applicable institutional and regulatory requirements.
Related trials for Melanoma (Skin Cancer)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin Cancer) and Basal Cell Carcinoma of Skin, run by Assuta Medical Center at 1 site in Israel.
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 4 inclusion and 1 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 21 Sep 2026. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and Proportion of Recognized Occupational Skin Cancer Cases by Cancer Type (time frame: Baseline (at initial recognition of the occupational skin cancer claim)). 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 NCT07831083, which also lists 5 linked publications.
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 21 Sep 2026.