- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06690918
Risk Factors Contributing to Oral Cancer in Patients at Dr. Hasan Sadikin General Hospital Bandung
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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West Java
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Bandung, West Java, Indonesia, 40161
- Universitas Padjajaran
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Oral cavity cancer group
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.
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Control group
The control group consisted of individuals attending the hospital for non-cancer-related conditions matched by age and sex to the case group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Risk factors for oral cavity cancer
Time Frame: 3 months
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Risk factors for oral cavity cancer will be listed
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Agung Adhariensya, MD, Faculty of Medicine Universitas Padjadjaran
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SURG-202411.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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