ClinicalTrials.gg
RecruitingNCT04236700Updated Mar 18, 2024

Buccal Evaluation of Mobile Beach Workers

An observational study in Buccal Cavity Cancer and Labial Lipoma, sponsored by Universidade Metropolitana de Santos. Recruiting at 2 sites in Brazil. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Universidade Metropolitana de Santos · Observational

From the registry’s dates

  • Started Nov 2019; still recruiting 6 years 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
300
Ages
20 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Buccal Cavity Cancer
  • Labial Lipoma

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Keywords

  • Buccal cancer
03

In context

Lipoma

22 studies on the registry are indexed under Lipoma; 6 are open to participants now.

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Lead sponsor

Universidade Metropolitana de Santos is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • be walking beach worker

Exclusion criteria

Exclusion Criteria:

  • not wanting to participate in the evaluation
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Other: Oral clinical exam

Interventions

  • OtherOral clinical exam

    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

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What researchers measure

Primary outcomes

  1. number of workers with labial injuries

    beach workers who do not adopt protective measures may have tissue damage to their lips

    Time frame: 2 months

07

Study locations

1 of 2 sites recruiting
  • Caio Vinicius Gonçalves Roman Torres
    Santos, SP 11015001, Brazil
    Recruiting
    • CAIO VINICIUS GONÇALVES G ROMAN TORRES · ContactCVGRT@HOTMAIL.COM · +5513991304774
  • Caio Torres
    Santos, SP 11045, Brazil
    Active, not recruiting

    Not enrolling at this site.

08

References and documents

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 3377516 ↗
  • Campisi 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. Erratum In: J Oral Pathol Med 2002 Sep;31(8):504. PubMed 11140896 ↗
  • English 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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2019 to primary completion in Mar 2022, 28 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2020
First posted
Jan 22, 2020
StartActual
Nov 22, 2019
Primary completionActual
Mar 27, 2022
CompletionEst.
Dec 27, 2025
Last update
Mar 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04236700
Lead sponsor
Universidade Metropolitana de Santos
Responsible party
CAIO VINICIUS G. ROMAN TORRES (Professor, Universidade Metropolitana de Santos) — Principal investigator
First posted
Jan 22, 2020
Start date
Nov 22, 2019
Primary completion
Mar 27, 2022
Completion
Dec 27, 2025 (estimated)
Last update
Mar 18, 2024

Study contacts

CAIO VINICIUS G ROMAN TORRES
Contact
CVGRT@HOTMAIL.COM
13991304774
CAIO VINICIUS G ROMAN TORRES
principal investigator · University of Santo Amaro

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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