NCT04236700

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2022

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2025

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

January 17, 2020

Last Update Submit

March 14, 2024

Conditions

Keywords

Buccal cancer

Outcome Measures

Primary Outcomes (1)

  • number of workers with labial injuries

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

    2 months

Study Arms (1)

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

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

beach workers

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • be walking beach worker

You may not qualify if:

  • not wanting to participate in the evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Caio Vinicius Gonçalves Roman Torres

Santos, São Paulo, 11015001, Brazil

RECRUITING

Caio Torres

Santos, São Paulo, 11045, Brazil

ACTIVE NOT RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Officials

  • CAIO VINICIUS G ROMAN TORRES

    University of Santo Amaro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CAIO VINICIUS G ROMAN TORRES

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 22, 2020

Study Start

November 22, 2019

Primary Completion

March 27, 2022

Study Completion

December 27, 2025

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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.

Locations