Clinical trial NCT06690918: Risk Factors Contributing to Oral Cancer in Patients at Dr. Hasan Sadikin General Hospital Bandung
Official title: Risk Factors Contributing to Oral Cancer in Patients at Dr. Hasan Sadikin General Hospital Bandung
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Cavity Cancer
Keywords: Oral cavity cancer
Risk factors
Smoking
Alcohol
Betel quid chewing
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 107
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was conducted at the oncology, ENT, and oral surgery outpatient clinics of the hospital from January 2023 to December 2024.

Brief summary: Analytical research with a cross-sectional approach was carried out on patients diagnosed with oral cavity cancer who visited our outpatient clinic in Bandung between 2023 and 2024. Data were collected and analyzed using the chi-square test to determine the significance of the relationship between smoking, alcohol consumption, oral hygiene, and betel quid chewing and oral cavity cancer.

Detailed description: This study was conducted using a cross-sectional analytical design, allowing the assessment of the association between various risk factors and oral cavity cancer. This study was conducted at the oncology, ENT, and oral surgery outpatient clinics at our hospital from January 2023 to December 2024. The inclusion criterion was a confirmed diagnosis of oral cavity cancer undergoing surgical intervention. Patients with oral cancer resulting from metastasis from a primary tumor located in another organ were excluded. The control group consisted of individuals attending the hospital for non-cancer-related conditions matched by age and sex to the case group.

Data were collected through structured interviews using a questionnaire designed to obtain information on subject behavior, including smoking, alcohol consumption, betel quid chewing, and oral hygiene practices. Medical records were reviewed to gather additional clinical information and to confirm the diagnosis of oral cavity cancer.

Data were analyzed using SPSS version 25. Descriptive statistics were used to summarize the demographic and clinical characteristics of the study population. The chi-squared test was used to assess the significance of the association between risk factors and the presence of oral cavity cancer. Statistical significance was set at P \< 0.05. The study was approved by the Health Research Ethics Committee (registration number DP.04.03/D.XIV.6.5/191/2024).

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of oral cavity cancer undergoing surgical intervention.

Exclusion Criteria:

* Oral cancer resulting from metastasis from a primary tumor located in another organ

Primary outcomes:
measure: Risk factors for oral cavity cancer
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Universitas Padjajaran
state: West Java
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran
name: Agung Adhariensya, MD
role: STUDY_CHAIR
References: