Oral Cavity CancerNCT06690918
Risk Factors Contributing to Oral Cancer in Patients at Dr. Hasan Sadikin General Hospital Bandung
An observational study of Oral Cavity Cancer, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Cavity Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 107 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2023to 4 Nov 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study was conducted at the oncology, ENT, and oral surgery outpatient clinics of the hospital from January 2023 to December 2024.
Who may be able to join
- Confirmed diagnosis of oral cavity cancer undergoing surgical intervention.
Who cannot join
- Oral cancer resulting from metastasis from a primary tumor located in another organ
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Oral Cavity Cancer
- Keywords
- Oral cavity cancer, Risk factors, Smoking, Alcohol, Betel quid chewing
- Medical subject headings
- Mouth Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for oral cavity cancer
Risk factors for oral cavity cancer will be listed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Jan 2023
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agung Adhariensya, MD, Study chair, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690918
- Sponsor's protocol ID
- SURG-202411.01
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Contributing to Oral Cancer in Patients at Dr. Hasan Sadikin General Hospital Bandung
- ClinicalTrials.gov ID
- NCT06690918
- Acronym / sponsor ID
- SURG-202411.01
- Conditions
- Oral Cavity Cancer
- Keywords
- Oral cavity cancer, Risk factors, Smoking, Alcohol, Betel quid chewing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 15 Nov 2024 (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.
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study was conducted at the oncology, ENT, and oral surgery outpatient clinics of the hospital from January 2023 to December 2024.
Key inclusion criteria (1 listed)
- Confirmed diagnosis of oral cavity cancer undergoing surgical intervention.
Key exclusion criteria (1 listed)
- Oral cancer resulting from metastasis from a primary tumor located in another organ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors for oral cavity cancer
Time frame: 3 months
Risk factors for oral cavity cancer will be listed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Agung Adhariensya, MD study chair
Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cavity Cancer, run by Universitas Padjadjaran at 1 site in Indonesia.
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: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors for oral cavity cancer (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024.