Buccal Cavity CancerNCT04236700
Buccal Evaluation of Mobile Beach Workers
An observational study of Buccal Cavity Cancer and Labial Lipoma, run by Universidade Metropolitana de Santos at 2 sites in Brazil.
Trial summary
Tumors in the oral region occur more frequently in men over 40, but can affect people of both gender and all ages, even children. The prevention of oral cancer acquires relevance in public health, particularly if the investigators consider that the preventive approach is compatible with the nature of this disease, as… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Buccal Cavity Cancer, Labial Lipoma
- What is being tested?
- Oral clinical exam
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 2 sitesBrazil
- Study dates
- 22 Nov 2019to 27 Dec 2025
- 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 20 to 70 years
- All sexes
- Adult, Older adult
Study population: The sample will consist of adult individuals of both sexes exposed to the sun directly and indirectly. The independent variables analyzed were: sex, age, income (in reais), years of study, type of work, frequency of weekly sun exposure, time of daily sun exposure, cumulative time of sun exposure and photoprotection measures at the occupational level. Health data will be collected on habits (alcoholism and smoking) and skin type, according to the Fitzpatrick classification
Who may be able to join
- be walking beach worker
Who cannot join
- not wanting to participate in the evaluation
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 1 recruiting
- Recruiting
Caio Vinicius Gonçalves Roman Torres
Santos, São Paulo, 11015001
CAIO VINICIUS GONÇALVES G ROMAN TORRES, +5513991304774, CVGRT@HOTMAIL.COM
- Active, not recruiting
Caio Torres
Santos, São Paulo, 11045
About this study
Official title: Oral and Buccal Evaluation of Mobile Beach Workers
Tumors in the oral region occur more frequently in men over 40, but can affect people of both gender and all ages, even children. The prevention of oral cancer acquires relevance in public health, particularly if the investigators consider that the preventive approach is compatible with the nature of this disease, as the mouth favors easy visual access. The objective of this study is evaluation the prevalence of oral and perioral injuries in workers who were exposed to the sun on the beaches, investigating possible associations of a sociodemographic, occupational and general health nature.
Read the detailed description
Tumors in the oral region occur more frequently in men over 40, but can affect people of both sexes and all ages, even children. The prevention of oral cancer acquires relevance in public health, particularly if the investigators consider that the preventive approach is compatible with the nature of this disease, as the mouth favors easy visual access. The objective of this study is evaluation the prevalence of oral and perioral injuries in workers who were exposed to the sun on the beaches, investigating possible associations of a sociodemographic, occupational and general health nature. Firstly, information about the care, symptoms and forms of prevention will be explained for each worker approached, if the individual agrees to an oral examination, it can be performed by evaluating lips and peri-oral mucosa and within the needs of oral treatment, it can be referred for treatment at the clinic of the Dentistry Especialist Center of Santos/SP The street vendors who underwent the first assessment will be visited 2 more times according to the schedule, after the carnival of 2020 being the last assessment and thus being able to have data on the effectiveness of the information and past care during the visits made. As expected results, a greater awareness of the dangers of sun exposure, greater protection care and the ability to carry out self-examination at home being an information disseminator.
- Conditions
- Buccal Cavity Cancer, Labial Lipoma
- Being tested
- Oral clinical exam
- Keywords
- Buccal cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral clinical examOther
Detailed anamnesis, with information regarding the time of sun exposure, protection measures, medical history and application of questionnaires will be carried out. Dental dental and tissue examination should be performed
| Study group | Role | What they receive |
|---|---|---|
| beach workers | Workers must undergo clinical examinations of the upper and lower lips, performed by previously calibrated researchers, through semi-technical inspection and palpation maneuvers, in order to identify injuries. Photo cameras can be used to improve the visibility of the lips using the image enhancement feature, to confirm the diagnosis. The clinical examination will include: dryness, atrophy, scaly lesions, lip swelling, erythema, ulcerations, cloudy demarcations between the vermilion of the lip and skin, demarcated folds along the lip, white spots or plaques, crusts, stained or pale areas.
They should be evaluated with the application of a previously validated questionnaire containing information related to personal data, information on occupation and health was completed according to the responses of the volunteers. The OHIP-14 quality of life questionnaire will be applied together Receives: Other: Oral clinical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of workers with labial injuries
beach workers who do not adopt protective measures may have tissue damage to their lips
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start22 Nov 2019
- Primary completion27 Mar 2022
- Study completion27 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Buccal Cavity CancerStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Metropolitana de Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos
- Investigators
- CAIO VINICIUS G ROMAN TORRES, Principal investigator, Universidade Santo Amaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236700
- Sponsor's protocol ID
- SantosMU7
- Status last verified
- Mar 2024
- First submitted
- 17 Jan 2020
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The collected data will be imported into the Stata 10.0 software platform. Descriptive analysis of all data related to dependent and independent variables, chi-square statistical tests and calculation of prevalence ratios and the respective confidence intervals. The multiple analysis will be performed using the robust Poisson regression by the hybrid method parameter to estimate the prevalence rates of lip lesions adjusted for sex, age, type of work, photo-protection measures, use of lip protector, use of cap / hat, skin type, any habit (smoking or drinking). The significance level of 5% will be adopted for all tests.
Publications
Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
PubMed 3377516Campisi G, Margiotta V. Oral mucosal lesions and risk habits among men in an Italian study population. J Oral Pathol Med. 2001 Jan;30(1):22-8. doi: 10.1034/j.1600-0714.2001.300104.x.
PubMed 11140896English DR, Armstrong BK, Kricker A, Fleming C. Sunlight and cancer. Cancer Causes Control. 1997 May;8(3):271-83. doi: 10.1023/a:1018440801577.
PubMed 9498892
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral and Buccal Evaluation of Mobile Beach Workers
- ClinicalTrials.gov ID
- NCT04236700
- Acronym / sponsor ID
- SantosMU7
- Conditions
- Buccal Cavity Cancer, Labial Lipoma
- Keywords
- Buccal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universidade Metropolitana de SantosUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 27 Mar 2022 (actual)
- Study completion
- 27 Dec 2025 (estimated)
- First posted
- 22 Jan 2020 (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.
Tumors in the oral region occur more frequently in men over 40, but can affect people of both gender and all ages, even children. The prevention of oral cancer acquires relevance in public health, particularly if the investigators consider that the preventive approach is compatible with the nature of this disease, as the mouth favors easy visual access. The objective of this study is evaluation the prevalence of oral and perioral injuries in workers who were exposed to the sun on the beaches, investigating possible associations of a sociodemographic, occupational and general health nature.
Detailed description
Tumors in the oral region occur more frequently in men over 40, but can affect people of both sexes and all ages, even children. The prevention of oral cancer acquires relevance in public health, particularly if the investigators consider that the preventive approach is compatible with the nature of this disease, as the mouth favors easy visual access. The objective of this study is evaluation the prevalence of oral and perioral injuries in workers who were exposed to the sun on the beaches, investigating possible associations of a sociodemographic, occupational and general health nature. Firstly, information about the care, symptoms and forms of prevention will be explained for each worker approached, if the individual agrees to an oral examination, it can be performed by evaluating lips and peri-oral mucosa and within the needs of oral treatment, it can be referred for treatment at the clinic of the Dentistry Especialist Center of Santos/SP The street vendors who underwent the first assessment will be visited 2 more times according to the schedule, after the carnival of 2020 being the last assessment and thus being able to have data on the effectiveness of the information and past care during the visits made. As expected results, a greater awareness of the dangers of sun exposure, greater protection care and the ability to carry out self-examination at home being an information disseminator.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| beach workers | – | Other: Oral clinical examWorkers must undergo clinical examinations of the upper and lower lips, performed by previously calibrated researchers, through semi-technical inspection and palpation maneuvers, in order to identify injuries. Photo cameras can be used to improve the visibility of the lips using the image enhancement feature, to confirm the diagnosis. The clinical examination will include: dryness, atrophy, scaly lesions, lip swelling, erythema, ulcerations, cloudy demarcations between the vermilion of the lip and skin, demarcated folds along the lip, white spots or plaques, crusts, stained or pale areas. They should be evaluated with the application of a previously validated questionnaire containing information related to personal data, information on occupation and health was completed according to the responses of the volunteers. The OHIP-14 quality of life questionnaire will be applied together |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The sample will consist of adult individuals of both sexes exposed to the sun directly and indirectly. The independent variables analyzed were: sex, age, income (in reais), years of study, type of work, frequency of weekly sun exposure, time of daily sun exposure, cumulative time of sun exposure and photoprotection measures at the occupational level. Health data will be collected on habits (alcoholism and smoking) and skin type, according to the Fitzpatrick classification
Key inclusion criteria (1 listed)
- be walking beach worker
Key exclusion criteria (1 listed)
- not wanting to participate in the evaluation
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 |
|---|---|---|
| Oral clinical examDetailed anamnesis, with information regarding the time of sun exposure, protection measures, medical history and application of questionnaires will be carried out. Dental dental and tissue examination should be performed | Other | beach workers |
Primary outcome
number of workers with labial injuries
Time frame: 2 months
beach workers who do not adopt protective measures may have tissue damage to their lips
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Results publication: PubMed 3377516Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
- Results publication: PubMed 11140896Campisi G, Margiotta V. Oral mucosal lesions and risk habits among men in an Italian study population. J Oral Pathol Med. 2001 Jan;30(1):22-8. doi: 10.1034/j.1600-0714.2001.300104.x.
- Results publication: PubMed 9498892English DR, Armstrong BK, Kricker A, Fleming C. Sunlight and cancer. Cancer Causes Control. 1997 May;8(3):271-83. doi: 10.1023/a:1018440801577.
- Individual participant dataSharing planned: No. The collected data will be imported into the Stata 10.0 software platform. Descriptive analysis of all data related to dependent and independent variables, chi-square statistical tests and calculation of prevalence ratios and the respective confidence intervals. The multiple analysis will be performed using the robust Poisson regression by the hybrid method parameter to estimate the prevalence rates of lip lesions adjusted for sex, age, type of work, photo-protection measures, use of lip protector, use of cap / hat, skin type, any habit (smoking or drinking). The significance level of 5% will be adopted for all tests.
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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.
CAIO VINICIUS G ROMAN TORRES principal investigator
Universidade Santo Amaro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Buccal Cavity Cancer and Labial Lipoma, run by Universidade Metropolitana de Santos at 2 sites in Brazil.
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 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CAIO VINICIUS G ROMAN TORRES (13991304774, CVGRT@HOTMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of workers with labial injuries (time frame: 2 months). 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 NCT04236700, which also lists 3 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 18 Mar 2024.